Clinical trial NCT06843993: Single-Ascending Dose Study of MK-2060 in Healthy Chinese Male Adult Participants (MK-2060-009)
Official title: A Single-Ascending Dose Clinical Trial to Study the Safety, Pharmacokinetics and Pharmacodynamics of MK-2060 in Healthy Chinese Male Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-02-25
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of the study is to learn about the safety of MK-2060 and if people tolerate it. Researchers also want to learn what happens to MK-2060 in a person's body over time.


Eligibility criteria: Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health before randomization
* Has a body mass index (BMI) ≥18 and ≤28 kg/m\^2.

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of cancer (malignancy)

Primary outcomes:
measure: Number of participants who experience one or more adverse events (AEs)
timeFrame: Up to 164 days
measure: Number of participants who discontinue study due to an AE
timeFrame: Up to 164 days
measure: Number of participants who experience one or more AEs related to bleeding
timeFrame: Up to 164 days
Secondary outcomes:
measure: Plasma concentration at end of infusion (Ceoi) of MK-2060
timeFrame: Predose Day 1 and end of infusion
measure: Plasma concentration at 168 hours (C168hr) of MK-2060
timeFrame: At designated timepoints (up to 168 hours)
measure: Area under the concentration versus time curve from 0 to infinity (AUC0-inf) of MK-2060
timeFrame: At designated timepoints (up to 150 days)
measure: AUC from 0 to 168 hours (AUC0-168) of MK-2060
timeFrame: At designated timepoints (up to 168 hours)
measure: Time to maximum observed plasma drug concentration (Tmax) of MK-2060
timeFrame: At designated timepoints (up to 150 days)
measure: Terminal half-life of MK-2060
timeFrame: At designated timepoints (up to 150 days)
measure: Clearance (CL) of MK-2060
timeFrame: At designated timepoints (up to 150 days)
measure: Volume of distribution (Vz) of MK-2060
timeFrame: At designated timepoints (up to 150 days)
measure: Change from baseline in activated partial thromboplastin time (aPTT)
timeFrame: Baseline (pre-dose) Day 1 and at designated timepoints (up to 150 days)
measure: Anti-drug antibodies (ADA) positive incidence
timeFrame: At designated timepoints (up to 150 days)
measure: Factor XI (FXI) activity level
timeFrame: At designated timepoints (up to 150 days)
measure: Prothrombin time (PT)
timeFrame: At designated timepoints (up to 150 days)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 001)
state: Shanghai
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: