Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 7:25 AM
Study NCT ID:
NCT07444294
Status:
RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single- and Multiple-Ascending Dose Study of SRK-439 in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-21', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-06-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-11', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants', 'timeFrame': 'Up to 32 weeks', 'description': '• Incidence of AEs'}, {'measure': 'Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants', 'timeFrame': 'Up to 32 weeks', 'description': '• Incidence of SAEs'}, {'measure': 'Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants', 'timeFrame': 'Up to 32 weeks', 'description': 'Changes from baseline in clinical safety laboratory tests (serum chemistry)'}, {'measure': 'Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants', 'timeFrame': 'Up to 32 weeks', 'description': 'Changes from baseline in clinical safety laboratory tests (hematology)'}, {'measure': 'Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants', 'timeFrame': 'Up to 32 weeks', 'description': 'Changes from baseline in clinical safety laboratory tests (urinalysis)'}, {'measure': 'Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants', 'timeFrame': 'Up to 32 weeks', 'description': 'Changes from baseline in clinical safety laboratory tests (coagulation assessments)'}, {'measure': 'Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants', 'timeFrame': 'Up to 32 weeks', 'description': 'Changes from baseline in vital signs (heart rate) measured in bpm'}, {'measure': 'Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants', 'timeFrame': 'Up to 32 weeks', 'description': 'Changes from baseline in vital signs (blood pressure) measured in mmHg'}, {'measure': 'Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants', 'timeFrame': 'Up to 32 weeks', 'description': 'Changes from baseline in vital signs (respiratory rate) measured in rpm'}, {'measure': 'Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants', 'timeFrame': 'Up to 32 weeks', 'description': 'Changes from baseline in vital signs (body temperature) measured in Celsius'}, {'measure': 'Evaluate the safety and tolerability of single and multiple SRK-439 SC dose administration in healthy adult participants', 'timeFrame': 'Up to 32 weeks', 'description': 'Changes from baseline in ECG measurements'}], 'secondaryOutcomes': [{'measure': 'Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants', 'timeFrame': 'Up to 32 weeks', 'description': '• Maximum observed serum concentration \\[Cmax\\]'}, {'measure': 'Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants', 'timeFrame': 'Up to 32 weeks', 'description': '• Time to maximum observed concentration in serum \\[Tmax\\]'}, {'measure': 'Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants', 'timeFrame': 'Up to 32 weeks', 'description': '• Area under the serum concentration-time curve \\[AUC\\]'}, {'measure': 'Evaluate the PK of single and multiple SRK-439 SC dose administration in healthy adult participants', 'timeFrame': 'Up to 32 weeks', 'description': '• Terminal elimination half-life in serum \\[t1/2\\]'}, {'measure': 'Evaluate the PD of single and multiple SRK-439 SC dose administration in healthy adult participants', 'timeFrame': 'Up to 32 weeks', 'description': 'Serum concentrations of total latent myostatin and changes over time'}, {'measure': 'Evaluate the immunogenicity of single and multiple SRK-439 SC dose administration in healthy adult participants', 'timeFrame': 'Up to 32 weeks', 'description': 'Incidence of ADAs against SRK-439 in serum'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SRK-439 in healthy adults'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Male or female participants, ≥18 to ≤55 years of age, at the time of informed consent\n2. BMI of ≥18 kg/m2 to ≤35 kg/m2 (inclusive) at screening\n\nExclusion Criteria:\n\n1. Previous treatment with SRK-439 or apitegromab, or with other anti-myostatin therapies, including ACTR antagonists.\n2. History of immunosuppressive, chemotherapeutic, or radiation treatment within 12 months prior to screening.\n3. Current or prior use of anabolic steroids, growth hormones, or other substances with known effects on muscle.\n4. Use of therapies with potentially significant muscle effects (eg, insulin-like growth factor, systemic beta-agonist, neurotoxins, or muscle relaxants or muscle-enhancing supplements) in any form within 3 months prior to screening or during the study.\n5. Any history of exposure to a mAb or Fc domain-bearing recombinant protein within 5 years prior to screening with any prior history of hypersensitivity reactions from exposure\n6. Treatment with other investigational drugs or devices in a clinical study or exposure to a biologic therapeutic within 3 months or 5 half-lives, whichever is longer, prior to screening.'}, 'identificationModule': {'nctId': 'NCT07444294', 'briefTitle': 'A Single- and Multiple-Ascending Dose Study of SRK-439 in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Scholar Rock, Inc.'}, 'officialTitle': 'A Phase 1 Single- and Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SRK-439 in Healthy Adults', 'orgStudyIdInfo': {'id': 'SRK-439-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A', 'description': 'Participants will be treated with a single dose of SRK-439 or matching placebo.', 'interventionNames': ['Drug: Placebo', 'Drug: SRK-439']}, {'type': 'EXPERIMENTAL', 'label': 'Part B', 'description': 'Participants will be treated with multiple doses of SRK-439 or matching placebo.', 'interventionNames': ['Drug: Placebo', 'Drug: SRK-439']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo to SRK-439, subcutaneous administration', 'armGroupLabels': ['Part A', 'Part B']}, {'name': 'SRK-439', 'type': 'DRUG', 'description': 'Single ascending dose, subcutaneous administration', 'armGroupLabels': ['Part A']}, {'name': 'SRK-439', 'type': 'DRUG', 'description': 'Multiple ascending dose, subcutaneous administration', 'armGroupLabels': ['Part B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45227', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Medpace CPU', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Scholar Rock, Inc. Clinical Trials Administration', 'role': 'CONTACT', 'email': 'MedicalInformation@scholarrock.com', 'phone': '857-259-3860'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scholar Rock, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}