A Study of AZD4205 in Healthy Adult Subjects

NCT03728023 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: DZ2018J0001
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to assess the safety, tolerability, pharmacokinetics of AZD4205 following single and multiple ascending dose in healthy adult subjects, and to assess the effect of food on the pharmacokinetics of AZD4205.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• The number of subjects with adverse events

  To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of adverse events (AEs)

  From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)

• The number of subjects with abnormal laboratory parameters

  To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal laboratory parameters

  From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)

• The number of subjects with abnormal vital signs

  To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal vital signs

  From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)

• The number of subjects with abnormal electrocardiogram

  To evaluate the safety and tolerability of AZD4205 versus placebo in healthy subjects at different dose levels in terms of abnormal electrocardiogram

  From screening up to 28 days after last dose (day29 for MAD, day 43 for food effect, day 42 for MAD)

Study Arms (2)

AZD4205

EXPERIMENTAL

Single ascending dose: 5mg, 20mg, 50mg, 100mg, 150mg Multiple ascending dose: low, medium and high dose once daily X 14 days

Drug: AZD4205

Placebo

PLACEBO COMPARATOR

placebo single dose in SAD and once daily for 14 days

Drug: Placebo

Interventions

AZD4205 DRUG

SAD: 5mg, 20mg, 50mg, 100mg and 150mg MAD: low, medium and high dose once daily X14 days

AZD4205

Placebo DRUG

Single dose in SAD and once daily for 14 days

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must be able to understand the nature of the trial and provide a signed and dated, written informed consent form prior to any study specific procedures, sampling and analyses.
• Female and/or male aged ≥18 \~ ≤ 45 years, with BMI ≥18\~≤ 28kg/m2.
• Female subjects must have negative pregnancy tests at screening and check-in AND: have been surgically sterile OR post-menopausal OR, if of child-bearing potential, must be using an acceptable method of contraception.
• Male subjects must be surgically sterile or using an acceptable method of contraception during the study and for 6 months after the last dose of AZD4205 or matching placebo to prevent pregnancy with a partner.

You may not qualify if:

• Evidence or reported history of clinically significant hematological (absolute neutrophil count \< 1.5 x 10\^3/μL; platelet count \< 100 x 10\^3/μL; hemoglobin \< 9 g/dL, INR \> 1.5), renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease determined by the investigator.
• Infections
• Received a live vaccine within 3 months before first dose of IP.

Sponsors & Collaborators

• Dizal Pharmaceuticals: lead

Study Sites (1)

Frontage clinical service

Secaucus, New Jersey, 07094, United States

Location

Related Publications (1)

• Chen K, Guan X, Yang Z, Zhou Y, Liu Z, Deng X, Liu D, Hu P, Chen R. Pharmacokinetic characteristics of golidocitinib, a highly selective JAK1 inhibitor, in healthy adult participants. Front Immunol. 2023 Apr 3;14:1127935. doi: 10.3389/fimmu.2023.1127935. eCollection 2023.

  PMID: 37077916 DERIVED

Study Officials

• Gregory J Tracey

  Frontage Clinical Services, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 28, 2018
• First Posted: November 1, 2018
• Study Start: November 12, 2018
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: August 24, 2020

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)