A Phase 1 Ethnobridging TriaL of AGA2118 in Healthy Japanese, Chinese, and Caucasian ParticipantS (ATLAS)

Angitia Biopharmaceuticals

Status and phase

Enrolling

Phase 1

Conditions

Pharmacokinetic Study

Healthy Participants

Treatments

Drug: AGA2118

Study type

Interventional

Funder types

Industry

Identifiers

NCT07361354

ACT24-006

Details and patient eligibility

About

This study will evaluate the effects of a single dose of AGA2118 in Japanese, Chinese, and Caucasian participants

Full description

This Phase 1 ethnobridging study will evaluate the pharmacokinetics, pharmacodynamics, and safety of AGA2118 in Japanese, Chinese, and Caucasian participants. Participants will be administered AGA2118 at the start of the study and followed for 85 days. Eighteen Japanese participants will be enrolled and randomized 1:1:1 to one of three doses of AGA2118 to be administered at a single timepoint. Following completion of dosing of the Japanese participants, 6 Caucasian participants will be enrolled to receive the highest dose at a single timepoint. They will be matched to Japanese participants (group average matching) by sex and weight. Additionally, 6 Chinese participants will be enrolled to receive a single administration of the highest dose. These participants may be enrolled at any time.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy males or females, aged 18 to 65 years
25-hydroxyvitamin D ≥30 ng/mL and agree to taking calcium and vitamin D supplements during the study
Meet the criteria for Japanese, Chinese, or Caucasian ethnicity

Exclusion criteria

Participating or have participated in another clinical trial within the past 6 months
Any bone fracture within the past 6 months
History of myocardial infarction or stroke within the past 12 months
Malignancy within the past 5 years
Current hyper- or hypocalcemia
Pregnant or breastfeeding women, or women planning to become pregnant during the study

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 5 patient groups

Cohort 1 (Japanese)

Experimental group

Description:

One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of low dose AGA2118.

Treatment:

Drug: AGA2118

Cohort 2 (Japanese)

Experimental group

Description:

One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of medium dose AGA2118.

Treatment:

Drug: AGA2118

Cohort 3 (Japanese)

Experimental group

Description:

One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of high dose AGA2118.

Treatment:

Drug: AGA2118

Cohort 4 (Caucasian)

Experimental group

Description:

Healthy Caucasian participants will receive a single administration of high dose AGA2118.