Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD5055 in Japanese and Chinese Healthy Volunteers..

NCT05955183 | Completed Phase 1 FDA Drug

• 1 other identifier: D8960C00005
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of AZD5055 after single and multiple doses, orally administered in healthy Japanese and Chinese participants.

Conditions

Healthy Participants

Keywords

Single ascending dose (SAD)

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  The safety and the tolerability after single and multiple doses of AZD5055 in healthy Japanese and Chinese participants will be evaluated.

  Until Follow-up (Day 7 ± 1 for Part 1 and Day 15 ± 1 for Part 2).

Secondary Outcomes (3)

• Maximum serum concentration (Cmax)

  Day 1 to Day 3 (Part 1) and Day 1 to Day 10 (Part 2)

• Area under plasma concentration-time curve from time 0 to infinity (AUCinf)

  Day 1 to Day 3 (Part 1) and Day 1 to Day 10 (Part 2)

• Area under plasma concentration-curve from time 0 to the last quantifiable concentration (AUClast)

  Day 1 to Day 3 (Part 1) and Day 1 to Day 10 (Part 2)

Study Arms (2)

AZD5055

ACTIVE COMPARATOR

Participants will orally receive AZD5055.

Drug: AZD5055; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Participants will orally receive placebo.

Drug: AZD5055; Drug: Placebo

Interventions

AZD5055 DRUG

AZD5055 will be given orally to randomized participants as per the arm they are assigned.

AZD5055; Placebo

Placebo DRUG

Placebo will be given orally to randomized participants as per the arm they are assigned.

AZD5055; Placebo

Eligibility Criteria

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

You may qualify if:

• For Chinese subjects only:
• Participant was born in greater China, including Hong Kong, Macau, and Taiwan.
• Participant has 2 Chinese biological parents and 4 Chinese grandparents as confirmed by interview.
• Participant did not live outside of greater China for more than 10 years at the time of the Screening Period.
• For Japanese subjects only:
• Participant was born in Japan.
• Participant has 2 Japanese biological parents and 4 Japanese grandparents as confirmed by the interview.
• Participant did not live outside of Japan for more than 10 years at the time of the Screening Period.
• Females must have a negative pregnancy test at the Screening Visit, must not be lactating and must be of non-childbearing potential.
• Males must adhere to the contraception methods.
• Have a Body mass index between 18 and 30 kg/m2 inclusive.

You may not qualify if:

• History of any clinically significant disease or disorder which may either put the participant at risk because of participation in the study or influence the results or the participant's ability to participate in the study.
• History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study drug.
• Any abnormal laboratory values.
• Participants with chronic infections (eg, urinary tract infection) or who are at increased risk of infection.
• History of cancer within the last 10 years.
• History of osteoporosis, osteomalacia, Paget's disease of the bone, thyrotoxicosis, rheumatoid arthritis, Cushing's disease, or a pathological fracture.
• History of traumatic fracture within 6 months of the Screening Visit.
• Participants will be excluded if
• In premenopausal women, men less than 50 years of age: Z-scores ≤ -2.0.
• In postmenopausal women and men aged 50 years and older: T-score ≤ -2.5.
• Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results.
• Abnormal vital signs.
• Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG.
• History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to AZD5055.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Glendale, California, 91206, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 21, 2023
• Study Start: July 27, 2023
• Primary Completion: December 4, 2023
• Study Completion: December 4, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Locations

US (1)