AGA2118 for Healthy Subjects
(ATLAS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the effects of a new treatment called AGA2118 in healthy Japanese, Chinese, and Caucasian participants. Researchers seek to understand how a single dose of this treatment affects these different ethnic groups. Healthy adults with normal vitamin D levels who belong to one of the specified ethnic groups might be a good fit for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Is there any evidence suggesting that AGA2118 is likely to be safe for humans?
Previous studies have shown that AGA2118 is safe and well-tolerated by participants. Research indicates that taking AGA2118, whether as a single dose or multiple doses, did not cause any major side effects. The number of unwanted effects was similar between those who received AGA2118 and those who received a placebo (a harmless pill or injection used in trials). This suggests that AGA2118 is generally safe for humans.12345
Why do researchers think this study treatment might be promising?
AGA2118 is unique because it targets a specific condition with a novel mechanism of action that isn't addressed by current standard treatments. Unlike most existing therapies, which may involve broader approaches or different pathways, AGA2118 is designed to work precisely at a new target site, potentially offering more effective results with fewer side effects. Researchers are particularly excited about its potential to deliver fast and noticeable improvements, possibly shortening the time it takes for patients to experience relief compared to existing options. Additionally, the study explores varying dosages across different ethnic groups, which could provide insights into personalized treatment strategies and optimize dosing for diverse populations.
What evidence suggests that AGA2118 could be effective in healthy subjects?
Research shows that AGA2118 is a promising treatment for improving bone health, particularly for individuals with osteoporosis, a condition where bones become weak and brittle. Studies have found that AGA2118, a lab-made protein that attaches to specific targets, effectively helps build bone. Previous research demonstrated that it significantly increased bone mineral density, a measure of bone strength. In this trial, participants will receive single doses of AGA2118. Past studies found that both single and multiple doses of AGA2118 were well-tolerated in healthy adults, indicating its potential safety. These encouraging results suggest that AGA2118 could effectively manage bone health conditions.12567
Are You a Good Fit for This Trial?
The ATLAS trial is for healthy men and women between 18 to 65 years old who have adequate levels of vitamin D. Participants must identify as Japanese, Chinese, or Caucasian and agree to take calcium and vitamin D supplements during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single administration of AGA2118 at the start of the study
Follow-up
Participants are monitored for pharmacokinetics, pharmacodynamics, and safety for 85 days post-dose
What Are the Treatments Tested in This Trial?
Interventions
- AGA2118
Trial Overview
This trial is testing a single dose of a new medication called AGA2118 on different ethnic groups: Japanese, Chinese, and Caucasian participants. It aims to observe how the drug behaves in their bodies (pharmacokinetics).
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Healthy Chinese participants will receive a single administration of high dose AGA2118.
Healthy Caucasian participants will receive a single administration of high dose AGA2118.
One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of high dose AGA2118.
One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of medium dose AGA2118.
One of three single ascending dose cohorts of healthy Japanese participants. Participants will receive a single administration of low dose AGA2118.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Angitia Incorporated Limited
Lead Sponsor
Citations
NCT05225857: AGA2118 Study
The primary objectives of the study are to assess the safety and tolerability of AGA2118 after single subcutaneous or intravenous administration in healthy ...
AGA2118, a Bispecific Monoclonal Antibody Neutralizing ...
Conclusion: Single and multiple doses of AGA2118 were well-tolerated and showed robust bone building efficacy in healthy adults. These data ...
A Phase 1 Ethnobridging TriaL of AGA2118 in Healthy ...
This Phase 1 ethnobridging study will evaluate the pharmacokinetics, pharmacodynamics, and safety of AGA2118 in Japanese, Chinese, and Caucasian participants.
AGA2118 – Application in Therapy and Current Clinical ...
AGA2118 is a new investigational medication being studied for the treatment of osteoporosis, particularly in postmenopausal women. Osteoporosis is a condition ...
5.
biospace.com
biospace.com/press-releases/angitia-biopharmaceuticals-presents-first-in-human-data-on-aga2118-for-osteoporosis-at-asbmr-2024Angitia Biopharmaceuticals Presents First-in-Human Data ...
Clinical data demonstrated treatment with AGA2118 resulted in dose-dependent increases in bone mineral density.
ANGITIA - INNOVATION FOR PATIENTS
AGA2118 was safe and well-tolerated at all dose levels tested, with adverse events balanced between treatment and placebo. No treatment-related ...
7.
finance.yahoo.com
finance.yahoo.com/news/angitia-biopharmaceuticals-presents-first-human-113000509.htmlAngitia Biopharmaceuticals Presents First-in-Human Data ...
AGA2118 was safe and well-tolerated at all dose levels tested, with adverse events balanced between treatment and placebo. No treatment-related ...
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