Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06402136
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-05-02
Brief Title:
Evaluation Safety Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of 83-0060 in Healthy Volunteers
Sponsor:
Traws Pharma Inc
Organization:
Traws Pharma Inc
Study Overview
Official Title:
A Randomised Double-Blind Placebo-Controlled First-in-Human Study of Orally Administered 83-0060 to Evaluate the Safety Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of 83-0060 in Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a clinical study aiming to assess pharmacokinetics pharmacodynamics and preliminary efficacy of 83-0060 in Healthy Volunteers
Detailed Description:
This is a Phase 1 double-blind placebo-controlled dose escalation study to evaluate the safety tolerability PK PD of orally administered 83-0060 in Healthy Volunteers The study will be conducted in 2 parts a single ascending dose SAD part at up to 5 dose levels and a multiple ascending dose MAD part at up to 3 dose levels Evaluation of dose levels will be conducted in a sequential fashion with lower dose levels evaluated first in the sequence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CT-2024-CTN-00084-1 | OTHER | therapeutic goods administration | None |