A Phase I Study to Evaluate the Safety/Tolerability of BDHK-2009 Tablets in Healthy Adult

NCT07632573 | Recruiting Phase 1 DMC

• 1 other identifier: BDHK-2009-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase 1, 2-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of BDHK-2009 (Part 1) and multiple oral doses (Part 2) of BDHK-200 in healthy adult participants.

Conditions

Ulcerative Colitis (Disorder); CD - Crohn's Disease; Ulcerative Colitis (UC); IBD (Inflammatory Bowel Disease); Ulcerative Colitis Acute

Keywords

Crohn's disease; Ulcerative Colitis; Inflammatory Bowel Disease; IBD; CD; UC

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerability of a single dose/multiple doses of BDHK-2009 in healthy participants.

  Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 6.0 including clinical significant changes in safety laboratory, vital signs, 12-lead ECG, and physical examination

  From enrollment to the end of treatment at week 4.

Secondary Outcomes (9)

• To evaluate the pharmacokinetics (PK) of a single dose/multiple doses of BDHK-2009 in healthy participants.

  From enrollment to the end of treatment at week 4.

• To evaluate the pharmacokinetics (PK) of a single dose/multiple dose of BDHK-2009 in healthy participants.

  From enrollment to the end of treatment at week 4.

• To evaluate the pharmacokinetics (PK) of a single dose/multiple dose of BDHK-2009 in healthy participants.

  From enrollment to the end of treatment at week 4.

• To evaluate the pharmacokinetics (PK) of a single dose/multiple doses of BDHK-2009 in healthy participants.

  From enrollment to the end of treatment at week 4.

• To evaluate the pharmacokinetics (PK) of a single dose/multiple doses of BDHK-2009 in healthy participants.

  From enrollment to the end of treatment at week 4.

Study Arms (2)

BDHK-2009 Tablets

EXPERIMENTAL

SAD1-6: Participants will be randomized to receive either single dose of BDHK-2009 Tablets. SAD 4 will be double blinded cross-over period is to determine food effect and participants will receive BDHK2009 Tablets under fed conditions in the second period. MAD is repeat ascending dose sequential period. There will three cohortsof 8 healthy subjects. In each cohort subjects will be randomized to receive BDHK-2009 Tablets or Placebo in ratio 3:1. Subjects will receive BDHK-2009 Tablets QD.

Drug: BDHK-2009 Tablets

Placebo

PLACEBO COMPARATOR

SAD1-6: Participants will be randomized to receive either single dose of Placebo. SAD 4 will be double blinded cross-over period is to determine food effect and participants will receive Placebo under fed conditions in the second period. MAD is repeat ascending dose sequential period. There will three cohortsof 8 healthy subjects. In each cohort subjects will be randomized to receive BDHK-2009 Tablets or Placebo in ratio 3:1. Subjects will receive Placebo QD.

Drug: Placebo

Interventions

BDHK-2009 Tablets DRUG

Administration: Oral

BDHK-2009 Tablets

Placebo DRUG

Administration: Oral

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 1. Participants who are able to communicate effectively with the investigator, understand and comply with the trial requirements, voluntarily participate in the trial, and understand and sign the informed consent form.
• \. Healthy participants aged 18 to 55 years (inclusive), regardless of gender. 3. Weight ≥ 50 kg (for males) and ≥ 45 kg (for females), with a body mass index (BMI) of 18-26 kg/m².
• \. At screening, physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory tests (including complete blood count, blood biochemistry, urinalysis, coagulation function, serological virology, thyroid function, etc.) results are either within normal limits or, if abnormal, not clinically significant.
• \. Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening and baseline, and must not be pregnant, lactating, or planning pregnancy during the study period. WOCBP must agree to use acceptable contraceptive measures during the treatment period and for at least 90 days after the last dose of the investigational product (whichever is longer).
• WOCBP is defined as any female who has experienced menarche and has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal;
• Non-childbearing potential females are defined as postmenopausal females and premenopausal females who have undergone sterilization surgery. Postmenopausal is defined as the absence of menstruation for ≥ 12 months without alternative medical intervention. Follicle-stimulating hormone (FSH) testing will be performed for subjects with uncertain status, and FSH \> 40 mIU/mL can confirm menopause.
• \. Male participants with partners of childbearing potential are eligible for the study only if they agree to use acceptable contraceptive measures during the treatment period and for at least 90 days after the last dose of the investigational product, and agree not to donate sperm during this period. In addition, male participants with partners of childbearing potential must use condoms continuously until at least 90 days after the last dose of the investigational product (whichever is longer).

You may not qualify if:

• \. As determined by the investigator, known or persistent psychiatric disorders requiring pharmacological intervention that may interfere with the participant's participation in the study, including but not limited to schizophrenia, bipolar disorder, or major depressive disorder.
• \. Participants with clinically significant abnormalities in any disease or condition, including but not limited to metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, psychiatric, thyroid, or other disorders, as determined by the investigator to be unsuitable for participation in this study.
• \. Presence or suspected presence of active viral, bacterial, fungal, or parasitic infection.
• \. History of recurrent or chronic infections.
• \. Participants with acute illness within 2 weeks prior to screening; participants with clinically significant infections (e.g., upper respiratory tract infection, nasopharyngitis, urinary tract infection, etc.) within 3 months prior to screening; participants with evidence of any infection within 7 days prior to screening; participants with a history of herpes simplex infection or recurrent (\>1 episode) herpes zoster or disseminated herpes zoster.
• \. History of epidemic meningococcal infection.
• \. History of splenectomy or functional asplenia.
• \. Participants with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV), HIV antibody (anti-HIV), or Treponema pallidum antibody.
• \. Participants with a history of active tuberculosis or evidence of active or latent tuberculosis infection at screening.
• \. Participants with a history of allergic tendencies, such as asthma, atopic dermatitis, chronic urticaria, or allergic rhinitis, or with allergies to two or more medications, foods, or pollens; participants with a history of hypersensitivity to the investigational drug or any of its components or to drugs with the same mechanism of action, or with clinically significant allergy history as determined by the investigator to be ineligible for enrollment.
• \. Participants who have participated in another interventional clinical study and received an interventional treatment (including investigational drugs and investigational medical devices) within 30 days prior to the first dose of the study drug, or within 5 half-lives of the study drug (whichever is longer).
• \. Participants with a history of drug abuse within 12 months prior to screening, or participants with positive urine drug screening results.
• \. Participants who have used any strong inducers or strong inhibitors of the hepatic metabolic enzyme CYP3A within 14 days or 5 half-lives prior to administration of the investigational drug (whichever is longer).
• \. Participants who have used any prescription medications within 14 days prior to administration of the investigational drug, or any over-the-counter medications, herbal medicines, or dietary supplements within 7 days prior to administration of the investigational drug, unless the investigator determines that the medication is not clinically significant.
• \. Participants who have consumed any foods or beverages containing substances that may induce or inhibit hepatic metabolic enzymes (such as grapefruit, Seville orange, or star fruit, etc.) within 7 days prior to administration of the investigational drug, or who are unable to avoid consumption of foods or beverages containing caffeine within 48 hours prior to administration of the investigational drug and throughout the inpatient study period.

Sponsors & Collaborators

• Benethera (Shaoxing) Biotechnology Co., Ltd.: lead

Study Sites (1)

Zhejiang Xiaoshan Hospital

Hangzhou, Zhejiang, 311200, China

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases; Crohn Disease

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Jinliang Chen

  Zhejiang Xiaoshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuang Zhang

CONTACT

+86-010-82146616; zhangshuang@benethera.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 8, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

CN (1)