Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:13 AM
Study NCT ID:
NCT07363395
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-23
First Post:
2026-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability, and Pharmacokinetics of ASCT-83 in Healthy Adults
Sponsor:
Alcamena Stem Cell Therapeutics
Organization:
Study Overview
Official Title:
A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASCT-83 Subcutaneous Injection in Healthy Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if ASCT-83 is safe and well-tolerated and measure how ASCT-83 is absorbed, distributed, and eliminated from the body over time. The study will be conducted in healthy adults.
The main questions this study will answer are:
* Is ASCT-83 safe at clinical doses?
* Does ASCT-83 have side effects at clinical doses?
* How is ASCT-83 absorbed, distributed, and eliminated from the body? Researchers will compare ASCT-83 to a placebo (a look-alike substance that contains no drug).
The study has two parts: participants in Part 1 will receive only one dose of ASCT-83 or placebo participants in Part 2 will receive one dose of ASCT-83 or placebo a day for 7 days. Participants will visit the clinic to take ASCT-83 or placebo, to receive health checkups and undergo health tests. Participants in Part 1 will spend 5 days/4 nights in the clinic, participants in Part 2 will spend 11 days/10 nights in the clinic. In addition, there will be up to 3 outpatient visits.
The results of this study will help determine safe dose levels and support the design of future clinical trials.
The main questions this study will answer are:
* Is ASCT-83 safe at clinical doses?
* Does ASCT-83 have side effects at clinical doses?
* How is ASCT-83 absorbed, distributed, and eliminated from the body? Researchers will compare ASCT-83 to a placebo (a look-alike substance that contains no drug).
The study has two parts: participants in Part 1 will receive only one dose of ASCT-83 or placebo participants in Part 2 will receive one dose of ASCT-83 or placebo a day for 7 days. Participants will visit the clinic to take ASCT-83 or placebo, to receive health checkups and undergo health tests. Participants in Part 1 will spend 5 days/4 nights in the clinic, participants in Part 2 will spend 11 days/10 nights in the clinic. In addition, there will be up to 3 outpatient visits.
The results of this study will help determine safe dose levels and support the design of future clinical trials.
Detailed Description:
Seventy-two healthy participants will be randomized to the following groups:
* Part 1, Single Ascending Dose (SAD): Healthy adult participants (age 18-64, inclusive) will be enrolled in 6 dose cohorts: 0.5 mg, 1 mg, 2 mg, 4 mg, 7.5 mg, or 10 mg. Each cohort consists of 8 participants (6 ASCT-83, 2 placebo), totaling 48 participants.
* Part 2, Multiple Ascending Dose (MAD): 3 dose cohorts of 8 participants each (6 ASCT-83, 2 placebo), totaling 24 participants. Dosing and regimens for Part 2 will be determined following review of SAD data by the Data Safety Monitoring Committee (DSMC).
All doses (ASCT-83 or placebo) will be administered as two subcutaneous (SC) injections (arm or thigh), with the second injection occurring within 10 minutes of the first.
The first two participants in every cohort - one administered ASCT-83 and one administered placebo - will be the sentinel participants. In every cohort, the two sentinel participants must be observed for 72 hours before the rest of the cohort is dosed.
The maximum dose escalation increment between any two cohorts will be two-fold. The maximum daily dose will not exceed the maximum tolerated dose established in the SAD study.
Additional cohorts may be recruited based on the emerging safety, tolerability, and PK data.
* Part 1, Single Ascending Dose (SAD): Healthy adult participants (age 18-64, inclusive) will be enrolled in 6 dose cohorts: 0.5 mg, 1 mg, 2 mg, 4 mg, 7.5 mg, or 10 mg. Each cohort consists of 8 participants (6 ASCT-83, 2 placebo), totaling 48 participants.
* Part 2, Multiple Ascending Dose (MAD): 3 dose cohorts of 8 participants each (6 ASCT-83, 2 placebo), totaling 24 participants. Dosing and regimens for Part 2 will be determined following review of SAD data by the Data Safety Monitoring Committee (DSMC).
All doses (ASCT-83 or placebo) will be administered as two subcutaneous (SC) injections (arm or thigh), with the second injection occurring within 10 minutes of the first.
The first two participants in every cohort - one administered ASCT-83 and one administered placebo - will be the sentinel participants. In every cohort, the two sentinel participants must be observed for 72 hours before the rest of the cohort is dosed.
The maximum dose escalation increment between any two cohorts will be two-fold. The maximum daily dose will not exceed the maximum tolerated dose established in the SAD study.
Additional cohorts may be recruited based on the emerging safety, tolerability, and PK data.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R44NS145934-01 | NIH | None | https://reporter.nih.gov/quic… | View |
| CDMRP-HT94252510912 | OTHER_GRANT | U.S. Army Medical Research Acquisition Activity (USAMRAA) | View |