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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-19

Study Completion Date

2023-10-28

Brief Summary

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

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Detailed Description

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

Conditions

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Healthy Subject

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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GS3-007 oral liquid

36 subjects，12 subjects in each dose group. Two dose groups were planned: 0.8 mg/kg and 1.6 mg/kg once a day for 4 weeks. According to the research progress of 1.6mg/kg QD, it was decided whether to add 0.8 mg/kg twice a day for 4 weeks.

Group Type EXPERIMENTAL

GS3-007 oral liquid

Intervention Type DRUG

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

Interventions

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GS3-007 oral liquid

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

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes