A Phase 1 Study of ANJ900 Chinese Healthy Subjects

NCT05151146 | Completed Phase 1 FDA Drug

• 1 other identifier: ANJ900D1104
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a Phase 1, randomised, open label, 3 way crossover study in healthy male and female Chinese subjects. Subjects will participate in 3 treatment periods and will be randomised in a 1:1:1 ratio to 1 of 3 treatment sequences. There will be a washout period of 7 days between doses.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Characterize the AUC of single oral dose of ANJ900 in healthy Chinese subjects

  ANJ900 levels in blood will be collected in serial draws

  1 week

• Characterize Cmax of a single oral dose of ANJ900 in healthy Chinese subjects

  ANJ900 levels in blood will be collected in serial draws

  1 week

Secondary Outcomes (2)

• Characterize the urine excretion from time zero to 24 hours post does of metformin

  1 week

• Assess the safety of ANJ900 in healthy Chinese subjects

  3 weeks

Study Arms (3)

ANJ900 in the fasted state

EXPERIMENTAL

Single dose (1800 mg) of ANJ900

Drug: ANJ900

ANJ900 in the fed state

EXPERIMENTAL

Single dose (1800 mg) of ANJ900

Drug: ANJ900

Metformin IR in the fasted state

ACTIVE COMPARATOR

Single dose (1000 mg) of metformin IR

Drug: Metformin IR

Interventions

ANJ900 DRUG

Metformin hydrochloride delayed-release tablets

Also known as: Met DR

ANJ900 in the fasted state; ANJ900 in the fed state

Metformin IR DRUG

metformin hydrochloride

Also known as: Met IR

Metformin IR in the fasted state

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese males or females between 18 and 65 years of age, inclusive.
• Body mass index between 18.5 and 28.0 kg/m2, inclusive, with a body weight \>50 kg (males) or \>45 kg (females).
• In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG (including heart rate ≥50 bpm, PR interval \<200 ms, and QRS duration \<120 ms), vital signs measurements (systolic blood pressure ≥90 and \<140 mmHg and diastolic blood pressure ≥50 and \<90 mmHg), and clinical laboratory evaluations at screening and Day -1 as assessed by the investigator (or designee).
• Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Appendix 3.
• Able to comprehend and willing to sign an ICF, remain at the study site, and to abide by the study restrictions.

You may not qualify if:

• Significant history or clinical manifestation of any metabolic, allergic (eg, asthma, urticaria, eczema dermatitis), dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
• Malignancy within 5 years (except basal cell skin carcinoma).
• History of a clinically significant disease that affects drug absorption, metabolism, or elimination processes, as determined by the investigator (or designee), including, but not limited to:
• inflammatory bowel disease, gastritis, ulcers, bile duct stones, or internal bleeding of the gastrointestinal tract or rectum
• gastrointestinal surgery (eg, anastomosis or bowel resection)
• pancreatic injury or pancreatitis
• urinary tract obstruction or difficulty passing urine.
• History of hypoglycaemic episodes, severe unconscious hypoglycaemia, or glucose metabolism disorders.
• History of significant hypersensitivity, intolerance, or allergy to any drug compound (eg, metformin), food, or other substance, unless approved by the investigator (or designee).
• Active symptoms, or a recent diagnosis of, coronavirus disease-19 (COVID-19).
• Donation or loss of \>500 mL of blood within 4 weeks prior to screening.
• Receipt of blood products within 8 weeks prior to screening.
• Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months.
• Poor peripheral venous access or intolerant of venous blood collection.
• Use or intend to use any prescription medications (with the exception of paracetamol \[≤4000 mg/day\] or ibuprofen \[≤2400 mg/day\]) within 4 weeks or 5 half lives, whichever is longer, prior to screening.

Sponsors & Collaborators

• Anji Pharma: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Haidan, China

Location

Study Officials

• Dongyang Liu, MD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

• Haiyan Liu, MD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: December 9, 2021
• Study Start: October 15, 2021
• Primary Completion: December 30, 2021
• Study Completion: February 28, 2022
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)