A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Axatilimab When Administered by Intravenous Infusion to Healthy Japanese Participants

JRCT ID: jRCT2071220109

Registered date:27/02/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: GVHD, healthy voluteer
• Date of first enrollment: 15/03/2023
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Cohort 1:
Axatilimab: A single protocol defined dose A of axatilimab will be administered.
Placebo: A single protocol defined dose of matching placebo will be administered.

Cohort 2:
Axatilimab: A single protocol defined dose B of axatilimab will be administered.
Placebo: A single protocol defined dose of matching placebo will be administered.

Outcome(s)

• Primary Outcome: Number of participants with Advers Events

Secondary Outcome

Pharmacokinetics Parameter :
Cmax of axatilimab
Cmin of axatilimab
tmax of axatilimab
AUC(0-t) of axatilimab
AUC(0-infinity) of axatilimab
CL of axatilimab
Vz of axatilimab
t1/2 of axatilimab

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 55age old
• Gender: Male

Include criteria

1. Male aged 18 to 55 years, inclusive at the time of signing the ICF.
2. Body weight defined in protocol inclusive at the time of screening.
3. No clinically significant findings on screening evaluation.
4. Male participants with reproductive potential must agree to take appropriate precautions to avoid fathering children from screening through 90 days after the dose of study drug on Day 1 and must refrain from donating sperm during this period.

Exclude criteria

1. History of clinically significant respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease.
2. History of cardiovascular, cerebrovascular, or peripheral vascular thrombotic disease or history of uncontrolled hypertension.
3. Blood pressure > 140/90 mm Hg at screening, confirmed by repeat testing.
4. History of rheumatologic/autoimmune disorders, except for minor eczema and rosacea.
5. Resting pulse < 40 bpm or > 100 bpm at screening, confirmed by repeat testing.
6. History or presence of an abnormal ECG before initial dose administration that, in the investigator's opinion, is clinically significant.
7. History of malignancy within 5 years of screening, with the exception of cured basal cell or squamous cell carcinoma of the skin.
8. Any major surgery within 24 weeks of screening.
9. Donation of >= 200 mL of whole blood within 4 weeks of screening or >= 400 mL of whole blood within 12 weeks of screening to a blood bank or for a clinical study (except a screening visit).
10. Blood transfusion within 4 weeks of check-in.
11. Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.
12. Positive test for active HBV or HCV infection or risk of reactivation of HBV or HCV. If HBsAg is negative and HBcAb and/or HBsAb is positive, HBV DNA should be measured. If HBV DNA is negative, the participant may be enrolled in the study with close monitoring of HBV activities. Participants positive for HCV antibody will be eligible if they are negative for HCV RNA.
13. Positive test for HIV.
14. History of alcoholism within 3 weeks of screening.
15. Positive breath or urine test for ethanol or positive urine screen for drugs of abuse that are not otherwise explained by permitted concomitant medications or diet.
16. Current treatment before the first dose of study drug with another investigational medication, or current enrollment in another investigational drug study.
17. History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator.
18. Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations, in the opinion of the investigator.
19. History of tobacco- or nicotine-containing product use within 4 weeks of screening. However, use of nicotine-containing products that are the equivalent to <= 2 cigarettes per week may be permitted at the discretion of the investigator.
20. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
21. Positive COVID-19 PCR test at the check-in.

Related Information

• Primary Sponsor: Ono Shintaro