To Evaluate the Safety and Tolerability of Multiple Doses of GS3-007a Oral Solution in Healthy Subjects.

To Evaluate the Safety and Tolerability of GS3-007a Oral Solution in a Multi-dose, Randomized, Open, Single-center Study in Healthy Chinese Adult Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05921890

Enrollment

Registered

2023-06-27

Start date

2023-06-19

Completion date

2023-10-28

Last updated

2023-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subject

Brief summary

To evaluate the safety and tolerability of GS3-007a oral solution after multiple oral administration in Chinese healthy adult subjects.

Detailed description

To evaluate the pharmacodynamic (PD) and pharmacokinetics（PK） characteristics of GS3-007a oral solution after multiple oral administration in Chinese healthy adult subjects

Interventions

DRUGGS3-007 oral liquid

The dosage was calculated according to body weight, once a day or twice a day.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy adult subjects aged 18-45 years (including boundary values), male or female; * Body mass index: 19-26 kg/m2 (including boundary values), male weight ≥50 kg, female weight ≥45 kg;

Exclusion criteria

* (Screening period consultation) accumulated two or more allergies to other drugs, food and environment; Or prone to rash, urticaria and other allergic symptoms; Or are known to be allergic to growth hormone-promoting peptide drugs or excipients of this preparation; * (screening period) have a clear history of neurological or mental disorders; Persons with incapacity or cognitive impairment; * ALT and AST exceed the upper limit of the normal range;

Design outcomes

Primary

Measure	Time frame
TEAEs	35 Days

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026