Healthy ParticipantsPhase 1NCT07075640
A Study to Determine the Safety and Tolerability of AG-236 and How it is Absorbed, Broken Down, and Eliminated From the Body in Healthy Participants
A Phase 1 study testing AG-236 in people with Healthy Participants, run by Agios Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The primary purpose of this study is to assess the safety and tolerability of a single dose of AG-236 administered subcutaneously in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AG-236
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to 31 Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female, of any race, between 18 and 55 years of age, inclusive.
- Females must be of nonchildbearing potential.
- Males must agree to use contraception.
- Males must agree not to donate sperm during the study and for 90 days or 5-half-lives of AG-236 in plasma, whichever is longer, after dose administration.
- Body mass index between 18.0 and 32.0 kilograms per square meter (kg/m2), inclusive.
- Body weight between 50 and 100 kg, inclusive.
- In good health, as determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG) and vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in, and from the physical examination at screening, as assessed by the investigator or designee.
- Able to comprehend and willing to sign the informed consent form (ICF) and abide by the study restrictions.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee.
- History of malignancy, with the exception of adequately treated non-melanomatous skin carcinoma.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator or designee.
- History or presence of iron deficiency or iron deficiency anemia and/or currently receiving oral or parenteral iron supplementation as treatment for those conditions or deemed high risk of iron deficiency as determined by the investigator.
- Males: ferritin <30 nanogram per millilitres (ng/mL) and/or transferrin saturation (TSAT): ≤25%.
- Females: ferritin <30 ng/mL and/or TSAT: ≤20%.
Show all 35Show fewer
- Fever (oral body temperature >38°C) or symptomatic viral or bacterial infection within 2 weeks prior to screening; evidence of intestinal infection (such as a participant-reported history of gastrointestinal symptoms [eg, nausea, vomiting, diarrhea] that are consistent, in the opinion of the investigator, with an acute viral or bacterial process) within 30 days prior to screening.
- Confirmed systolic blood pressure >140 or <90 millilitres of mercury (mmHg), diastolic blood pressure >90 or <50 mmHg, or pulse rate >100 or <40 beats per minute. If any parameter is out of range, measurements should be repeated twice. Participants will be excluded if the average of the 3 measurements are outside of the corresponding reference range.
- Clinically significant abnormality, as determined by the investigator, on ECG performed at screening or check-in or any of the following:
- QT interval corrected for heart rate using Fridericia's formula (QTcF) >450 milliseconds (ms) in males or >470 ms in females, confirmed by calculating the mean of the triplicate values obtained
- history of additional risk factors for torsades de pointes (eg, heart failure, hypokalemia, or family history of long QT syndrome).
- Clinical laboratory values that are outside the normal reference range and are considered clinically significant, as determined by the investigator.
- Clinical laboratory values for hemoglobin (Hb) for males <13.8 grams per decilitres g/dL and females <12.1 g/dL.
- Clinical laboratory values for aspartate aminotransferase (AST), alanine aminotransferase (ALT) and/or total bilirubin >1 × upper limit of normal (ULN).
- Participants will be excluded if a single repeat confirms the result.
- Positive hepatitis panel and/or positive human immunodeficiency virus test.
- Participants whose results are compatible with prior immunization may be included.
- Clinical laboratory value for partial thromboplastin time (PTT) >1 × ULN and/or International Normalized Ratio (INR) >1.2. Participants will be excluded if a single repeat confirms the result.
- Administration of any vaccine within 30 days prior to dosing.
- Use or intend to use during the study duration any prescription medications/products, including hormone replacement therapy, within 28 days prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
- Use or intend to use during the study duration any slow-release medications/products considered to still be active within 28 days prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
- Use or intend to use during the study duration any nonprescription medications/products including vitamins (including iron-containing multivitamins), minerals, biotin supplements, recreational drugs, or phytotherapeutic/herbal/plant-derived preparations within 28 days prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
- Participation in a clinical study involving administration of an IMP (new chemical entity) in the past 30 days or 5 half-lives of that drug (if known) prior to dosing, whichever is longer.
- Have previously completed or withdrawn from this study or any other study investigating AG-236 and have previously received AG-236.
- Alcohol consumption of >14 units per week for males and females. One unit of alcohol equals 12 ounces (oz) (360 mL) beer, 1½ oz (45 mL) liquor, or 5 oz (150 mL) wine.
- Positive urine drug screen at screening or positive alcohol test result or positive urine drug screen at check-in.
- History of alcoholism or drug/chemical abuse within 2 years prior to check-in.
- Use of tobacco- or nicotine-containing products within 3 months prior to check-in, or positive cotinine at screening or check-in.
- Have special dietary restrictions or inability to consume standard meals as required in the study.
- Receipt of blood products within 2 months prior to check in.
- Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
- Poor peripheral venous access.
- Participants who, in the opinion of the investigator or designee, should not participate in this study.
- Increased risk of thrombosis, as determined by the investigator or designee.
- Clinical laboratory value for homocysteine >1 × ULN.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Research Unit Inc.
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-Ascending Dose Safety, Tolerability, and Pharmacokinetic Study of AG-236 Administered as a Subcutaneous Dose in Healthy Male and Female Participants
The primary purpose of this study is to assess the safety and tolerability of a single dose of AG-236 administered subcutaneously in healthy participants.
- Conditions
- Healthy Participants
- Being tested
- AG-236, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG-236Drug
Subcutaneous (SC) Injection
PlaceboDrug
SC Injection
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Experimental | Participants will receive a single dose of AG-236 at dose level 1 or placebo on Day 1 under fasted conditions. Receives: Drug: AG-236; Drug: Placebo |
| Treatment Group B | Experimental | Participants will receive a single dose of AG-236 at dose level 2 or placebo on Day 1 under fasted conditions. Receives: Drug: AG-236; Drug: Placebo |
| Treatment Group C | Experimental | Participants will receive a single dose of AG-236 at dose level 3 or placebo on Day 1 under fasted conditions. Receives: Drug: AG-236; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Type, Severity, and Relationship to Study Drug
Measured: Up to Day 57
Secondary outcomes (15)
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of AG-236
Measured: Predose and multiple time points postdose from Day 1 to Day 57
Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of AG-236
Measured: Predose and multiple time points postdose from Day 1 to Day 57
Maximum Observed Plasma Concentration (Cmax) of AG-236
Measured: Predose and multiple time points postdose from Day 1 to Day 57
Percentage of Area Under the Concentration-Time Curve due to Extrapolation From the Last Quantifiable Concentration to Infinity (AUC%extrap) of AG-236
Measured: Predose and multiple time points postdose from Day 1 to Day 57
Time to Last Measurable Concentration (tlast) of AG-236
Measured: Predose and multiple time points postdose from Day 1 to Day 57
Time to Reach Maximum Observed Plasma Concentration (tmax) of AG-236
Measured: Predose and multiple time points postdose from Day 1 to Day 57
Terminal Elimination Half-Life (t1/2) of AG-236
Measured: Predose and multiple time points postdose from Day 1 to Day 57
Apparent Total Body Clearance (CL/F) of AG-236
Measured: Predose and multiple time points postdose from Day 1 to Day 57
Apparent Volume of Distribution (Vz/F) of AG-236
Measured: Predose and multiple time points postdose from Day 1 to Day 57
Amount of Unchanged AG-236 Excreted in Urine From Day 1 to Day 3 (Aet1-t2)
Measured: Predose and multiple time points postdose from Day 1 to Day 3
Cumulative Amount of Unchanged AG-236 Excreted in Urine (Cum Aeu)
Measured: Predose and multiple time points postdose from Day 1 to Day 3
Percentage of AG-236 Dose Excreted Unchanged in Urine From Day 1 to Day 3 (fet1-t2)
Measured: Predose and multiple time points postdose from Day 1 to Day 3
Cumulative Percentage of AG-236 Dose Excreted Unchanged in Urine (Cum fe)
Measured: Predose and multiple time points postdose from Day 1 to Day 3
Renal Clearance (CLR) of AG-236
Measured: Predose and multiple time points postdose from Day 1 to Day 3
Change From Baseline in Serum Hepcidin Levels
Measured: Baseline, Days 2, 3, 8, 29, and 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start7 Jul 2025
- Primary completion11 Feb 2026
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Agios Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agios Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075640
- Sponsor's protocol ID
- AG236-C-001
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-Ascending Dose Safety, Tolerability, and Pharmacokinetic Study of AG-236 Administered as a Subcutaneous Dose in Healthy Male and Female Participants
- ClinicalTrials.gov ID
- NCT07075640
- Acronym / sponsor ID
- AG236-C-001
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Agios Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 11 Feb 2026 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to assess the safety and tolerability of a single dose of AG-236 administered subcutaneously in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Experimental | Drug: AG-236, Drug: PlaceboParticipants will receive a single dose of AG-236 at dose level 1 or placebo on Day 1 under fasted conditions. |
| Treatment Group B | Experimental | Drug: AG-236, Drug: PlaceboParticipants will receive a single dose of AG-236 at dose level 2 or placebo on Day 1 under fasted conditions. |
| Treatment Group C | Experimental | Drug: AG-236, Drug: PlaceboParticipants will receive a single dose of AG-236 at dose level 3 or placebo on Day 1 under fasted conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male or female, of any race, between 18 and 55 years of age, inclusive.
- Body mass index between 18.0 and 32.0 kilograms per square meter (kg/m2), inclusive.
- Body weight between 50 and 100 kg, inclusive.
- In good health, as determined by no clinically significant findings from medical history, 12-lead electrocardiogram (ECG) and vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in, and from the physical examination at screening, as assessed by the investigator or designee.
- Able to comprehend and willing to sign the informed consent form (ICF) and abide by the study restrictions.
Key exclusion criteria (35 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee.
- History of malignancy, with the exception of adequately treated non-melanomatous skin carcinoma.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator or designee.
- History or presence of iron deficiency or iron deficiency anemia and/or currently receiving oral or parenteral iron supplementation as treatment for those conditions or deemed high risk of iron deficiency as determined by the investigator.
- Fever (oral body temperature >38°C) or symptomatic viral or bacterial infection within 2 weeks prior to screening; evidence of intestinal infection (such as a participant-reported history of gastrointestinal symptoms [eg, nausea, vomiting, diarrhea] that are consistent, in the opinion of the investigator, with an acute viral or bacterial process) within 30 days prior to screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AG-236Subcutaneous (SC) Injection | Drug | Treatment Group A, Treatment Group B, Treatment Group C |
| PlaceboSC Injection | Drug | Treatment Group A, Treatment Group B, Treatment Group C |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Type, Severity, and Relationship to Study Drug
Time frame: Up to Day 57
15 secondary outcomes
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of AG-236
Time frame: Predose and multiple time points postdose from Day 1 to Day 57
Area Under the Concentration-time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of AG-236
Time frame: Predose and multiple time points postdose from Day 1 to Day 57
Maximum Observed Plasma Concentration (Cmax) of AG-236
Time frame: Predose and multiple time points postdose from Day 1 to Day 57
Percentage of Area Under the Concentration-Time Curve due to Extrapolation From the Last Quantifiable Concentration to Infinity (AUC%extrap) of AG-236
Time frame: Predose and multiple time points postdose from Day 1 to Day 57
Time to Last Measurable Concentration (tlast) of AG-236
Time frame: Predose and multiple time points postdose from Day 1 to Day 57
Time to Reach Maximum Observed Plasma Concentration (tmax) of AG-236
Time frame: Predose and multiple time points postdose from Day 1 to Day 57
Terminal Elimination Half-Life (t1/2) of AG-236
Time frame: Predose and multiple time points postdose from Day 1 to Day 57
Apparent Total Body Clearance (CL/F) of AG-236
Time frame: Predose and multiple time points postdose from Day 1 to Day 57
Apparent Volume of Distribution (Vz/F) of AG-236
Time frame: Predose and multiple time points postdose from Day 1 to Day 57
Amount of Unchanged AG-236 Excreted in Urine From Day 1 to Day 3 (Aet1-t2)
Time frame: Predose and multiple time points postdose from Day 1 to Day 3
Cumulative Amount of Unchanged AG-236 Excreted in Urine (Cum Aeu)
Time frame: Predose and multiple time points postdose from Day 1 to Day 3
Percentage of AG-236 Dose Excreted Unchanged in Urine From Day 1 to Day 3 (fet1-t2)
Time frame: Predose and multiple time points postdose from Day 1 to Day 3
Cumulative Percentage of AG-236 Dose Excreted Unchanged in Urine (Cum fe)
Time frame: Predose and multiple time points postdose from Day 1 to Day 3
Renal Clearance (CLR) of AG-236
Time frame: Predose and multiple time points postdose from Day 1 to Day 3
Change From Baseline in Serum Hepcidin Levels
Time frame: Baseline, Days 2, 3, 8, 29, and 57
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AG-236 in people with Healthy Participants, run by Agios Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) by Type, Severity, and Relationship to Study Drug (time frame: Up to Day 57). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.