NCT07279636

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Jul 2025

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
Last Updated

June 30, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

November 29, 2025

Last Update Submit

June 28, 2026

Conditions

Healthy Volunteers

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

EXPERIMENTAL
Drug: Alpha-0261

Single Ascending Dose (placebo)

PLACEBO COMPARATOR
Other: Placebo

Interventions

Alpha-0261DRUG

Oral, tablet

Single Ascending Dose
PlaceboOTHER

Oral, tablet

Single Ascending Dose (placebo)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

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

February 14, 2026

Study Completion

April 15, 2026

Last Updated

June 30, 2026

Record last verified: 2026-06

Locations

CN(1)