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NCT Number: NCT07373457

A Phase I Study of HW201877 in Healthy Subjects

This is a Phase I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW201877 in healthy subjects following (1) a single ascending dose (Part 1), which includes a single-dose, two-period crossover FE cohort; (2) a multiple ascending dose (Part 2).

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Before enrollment in the study, each subject shall sign the informed consent form and be fully apprised of the study content, implementation procedures and potential adverse reactions.
  • Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 6 months after the last dose administration.
  • 18 years to 55 years (inclusive), male and female.
  • Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Bodymass index (BMI) : 18-28 kg/m2 (inclusive) .

Key Exclusion Criteria:

  • Smoking more than 5 cigarettes per day within 3 months prior to screening.
  • Allergic diathesis (with a history of allergies to multiple drugs and foods).
  • A history of drug abuse and/or alcoholism (consuming 14 units of alcohol per week; 1 unit = 285 mL of beer, 25 mL of distilled spirits, or 100 mL of wine).
  • Have taken any medications that alter hepatic enzyme activity within 28 days prior to screening.
  • Have consumed special diets (including pitaya, mango, lime, grapefruit, carambola, orange, grapefruit or grapefruit-containing products, etc.) or engaged in strenuous exercise within 2 weeks prior to screening, or having other factors that may affect the absorption, distribution, metabolism and excretion of the study drug.
  • Have taken any investigational drugs or participated in any other clinical drug trials within 3 months prior to the first administration of the study drug.
  • Clinically significant abnormalities in clinical laboratory tests, or a history of clinically significant findings of the following diseases within 12 months prior to screening (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immunological, psychiatric, or cardio-cerebrovascular diseases).
  • Unable to tolerate venipuncture, or with a history of needle phobia or hematophobia.
  • Not suitable for this study as judged by the investigator.

Treatment and study plan

HW201877 capsules

Drug

Dose 1 to Dose 7

Placebo

Drug

Dose 1 to Dose 7

Primary outcomes

  1. The number and severity of treatment emergent adverse events (TEAEs)

    Time frame: Day 1 to Day 5

    To assess the safety and tolerability of single or multiple oral dose of HW201877 in healthy adult volunteers

Sponsors and collaborators

Lead sponsor

Wuhan Humanwell Innovative Drug Research and Development Center Limited Company

Industry

Registry information

Official study title

A Single-Center, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dosing, Dose-escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, PK/PD, Food Effect of HW201877 in Healthy Volunteers.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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