A Study to Evaluate Single Doses of Alpha-0261 in Healthy Adult Volunteers
A Randomized, Double-blind, Placebo-Controlled, Dose-Escalation, Phase Ia Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Oral Administration of Alpha-0261 Tablets in Adult Healthy Participants
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Alpha-0261 tablets after single oral administration in healthy adult volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy-volunteers
Started Jul 2025
Typical duration for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 21, 2025
CompletedFirst Submitted
Initial submission to the registry
November 29, 2025
CompletedFirst Posted
Study publicly available on registry
December 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 20, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2026
ExpectedDecember 12, 2025
December 1, 2025
8 months
November 29, 2025
December 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of treatment emergent adverse events
From enrollment to end of follow-up visit, up to approximately 1 week
Secondary Outcomes (6)
Plasma PK of Alpha-0261 after single dose
From enrollment to end of treatment period, up to approximately 7 days
Plasma PK of Alpha-0261 after single dose
From enrollment to end of treatment period, up to approximately 7 days
Plasma PK of Alpha-0261 after single dose
From enrollment to end of treatment period, up to approximately 7 days
Plasma PK of Alpha-0261 after single dose
From enrollment to end of treatment period, up to approximately 7 days
Plasma PK of Alpha-0261 after single dose
From enrollment to end of treatment period, up to approximately 7 days
- +1 more secondary outcomes
Study Arms (2)
Single Ascending Dose
EXPERIMENTALSingle Ascending Dose (placebo)
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Aged ≥ 18 and ≤ 55, male or female
- Weight: ≥ 50 kg for males, ≥ 45 kg for females; 19 kg/m2 ≤ body mass index (BMI) ≤ 28 kg/m2
- In general good health
You may not qualify if:
- Have a history of any severe allergic reaction or anaphylaxis
- Any condition, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol
- Have clinically significant abnormalities on clinical laboratory results
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bishan Hospital of Chongqing
Chongqing, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2025
First Posted
December 12, 2025
Study Start
July 21, 2025
Primary Completion
March 20, 2026
Study Completion (Estimated)
May 30, 2026
Last Updated
December 12, 2025
Record last verified: 2025-12