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A Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of Oral Doses of H008

NCT05050188 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-12-15

No results posted yet for this study

Summary

This will be a Phase I, randomized, double-blind, positive- and placebo-controlled study to evaluate the safety, tolerability, and PK/PD of multiple oral doses of H008 in healthy adult subjects.

Two dose levels of H008 at 20 mg and 40 mg will be studied in two sequential cohorts. Each cohort will be enrolled with 12 subjects (8 on H008, 2 on placebo and 2 on positive control drug). Subjects are only allowed to participate in one of the two cohorts. Both the investigational product and placebo will be given in a double blinded manner, while the positive control drug will be given in an open-label manner.Dose escalation to the next cohort will be permitted only when safety data until follow-up and PK data until 48 hours post-last dose, from all subjects in previous cohorts are reviewed, and the investigational product is deemed well tolerated.

The study will consist of a screening period, a baseline period, a 7-day repeated-dose period and a safety follow-up period.

Conditions

  • Erosive Esophagitis

Interventions

DRUG

H008

Drug administration after a minimum 10-hour overnight fasting. Subjects will be instructed to take the drugs with approximately 240 ml (8 oz) room temperature water.

DRUG

H008 placebo

Drug administration after a minimum 10-hour overnight fasting. Subjects will be instructed to take the drugs with approximately 240 ml (8 oz) room temperature water

DRUG

Lansoprazole

Drug administration after a minimum 10-hour overnight fasting. Subjects will be instructed to take the drugs with approximately 240 ml (8 oz) room temperature water

Sponsors & Collaborators

  • Jiangsu Carephar Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-06-24
Primary Completion
2021-09-18
Completion
2021-09-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05050188 on ClinicalTrials.gov