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A Phase 1 Study of ISM4808 in Healthy Adult Subjects

NCT07415304 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-02-17

No results posted yet for this study

Summary

This is a Phase I, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), food effect, and QTc effects of single and multiple ascending oral doses of ISM4808 in healthy adult subjects.

Conditions

  • Healthy Volunteers

Interventions

DRUG

ISM4808

ISM4808 administered orally as capsules in single ascending dose and multiple ascending dose regimens, with flexible dosing schedules based on emerging safety and pharmacokinetic data.

DRUG

Placebo

Matching placebo administered orally under the same conditions as ISM4808.

Sponsors & Collaborators

  • R&G Pharma Studies Co.,Ltd.

    collaborator INDUSTRY

  • TaiGen Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Gan Zhou · Xiangya Hospital of Central South University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-13
Primary Completion
2026-11-30
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07415304 on ClinicalTrials.gov