Healthy VolunteersPhase 1NCT06286475
A Study of VRG50635 in Healthy Volunteers
A Phase 1 study testing VRG50635 in people with Healthy Volunteers, run by Verge Genomics at 1 site in United States.
Trial summary
The primary objectives of this study are to investigate the safety and tolerability of VRG50635 and to determine how VRG50635 is absorbed by the body. Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- VRG50635
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Feb 2024to 8 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be ≥ 19 and ≤ 55 years of age at Screening.
- Must be willing and able to voluntarily give written informed consent by signing an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form prior to any study-related procedures being performed.
- Must have a body mass index ≥ 18.5 and ≤ 32 kilogram per square meter (kg/m2) and weigh ≥ 50 kg.
- Participants of childbearing potential are eligible to participate if they are not pregnant or breastfeeding and agree to use one highly effective and one barrier method of contraception, if sexually active, for the duration of the study through 90 days after the last study drug administration. Participants must not donate eggs for the duration of study through 90 days after the last dose of study drug.
- Participants capable of producing sperm must agree that they will use one barrier method of contraception and that their partners of childbearing potential will use one highly effective method of contraception for the duration of the study through 90 days after the last study drug administration. Participants must not donate sperm for the duration of study through 90 days after the last dose of study drug.
Who cannot join
- Have a history of clinically significant hematologic, renal, neurologic, pancreatic, gastrointestinal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, immunological, allergic disease, or other major disorders, as determined by the PI.
- Have any surgical or medical condition that could possibly affect drug absorption (including inflammatory bowel disease, history of gastrectomy, cholecystectomy, or other gastrointestinal tract surgery except appendectomy).
- Have a current significant medical or psychiatric condition, as determined by the PI.
- Have a history of serious adverse reaction or serious hypersensitivity to any drug.
- Have, in the opinion of the PI, evidence of clinically significant hepatic or renal impairment including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > the upper limit of normal (ULN) or bilirubin > 1.5 × ULN. Note: Participants with Gilbert syndrome without evidence of hepatic impairment may be enrolled.
- Have a history or presence of an abnormal electrocardiogram (ECG), including, but not limited to, complete left bundle branch block, second- or third-degree heart block, evidence of prior myocardial infarction, or any other abnormality that is clinically significant in the PI's opinion or precludes accurate interpretation and calculations of cardiac intervals (e.g., QT, QRS).
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- Have clinically significant abnormalities, as assessed by the PI, in laboratory tests at the screening and admission visits. Note: Participants may be rescreened at the discretion of the PI with Sponsor approval.
- Have abnormal blood pressure: supine systolic blood pressure < 90 or > 140 mmHg, supine diastolic blood pressure < 50 or > 90 mmHg, pulse rate < 40 or > 100 bpm, and body temperature < 35.4 or > 37.8 °C (< 96 or > 100.3 °F) at the screening and admission visits.
- Have a prolonged corrected QT interval using Fridericia's formula (QTcF) during the 12- lead ECG at Screening or pre-dose on Day 1 > 450 ms for participants assigned male at birth and > 470 ms for participants assigned female at birth.
- Have a hemoglobin level < 12 g/dL (participants assigned male at birth) or < 10.5 g/dL (participants assigned female at birth).
- Have participated in any other investigational drug study within 30 days of dosing or within 7 half-lives of the investigational product, whichever is longer, or have previously participated in the current study.
- Use any prescription medication within 7 days or 5 half-lives (whichever is longer) of the first dose administration and/or anticipated use through the follow-up visit.
- Use any over-the-counter medication (including vitamin/mineral supplements and herbal medicines, such as St. John's wort and non-standard herbal teas) within 7 days of the first dose administration and/or anticipate using through study participation and the follow-up visit.
- Receive a positive result in a SARS-CoV-2 test or a COVID-19 vaccine within 30 days prior to Screening.
- Have poor peripheral venous access.
- Have donated blood or plasma or otherwise lost ≥ 500 mL of blood within 8 weeks of Screening.
- Have consumed alcohol, caffeine, or cytochrome P450 (CYP)-altering foods within 48 hours prior to dosing.
- Have an average daily caffeine intake > 800 mg/day (equivalent to approximately 8 cups of coffee per day).
- Have a documented medical history of alcoholism or current use of more than 21 units of alcohol per week, of drug abuse, or of drug addiction in the last 2 years.
- Have a positive drug or alcohol test at Screening.
- Use tobacco or nicotine products (including tobacco- or nicotine-containing products in any form, including e-cigarettes and vaping) within 90 days before Screening or have a positive nicotine test at the screening or admission visit.
- Have a history of suicidal behavior or suicidal ideation within the past 60 months, as determined by a positive response ("Yes") to either question 4 or question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening.
- Have one or more of the following laboratory test abnormalities at Screening: (a) Positive hepatitis C virus (HCV) antibodies; (b) Positive hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb); (c) Positive HIV 1/2 antibodies.
- Engage in strenuous activity (including exercise) for ≥ 1 hour within 48 hours of any study day.
- Are part of the clinical staff personnel or have family members of the clinical site staff or the Sponsor.
- Have any other issue which, in the opinion of the PI, will make the participant ineligible for study participation.
- Multiple Dose Part only: Are not eligible for lumbar puncture (have anticoagulation, antiaggregation, or blood coagulation pathologies, history of lumbar spine surgery, acquired or congenital spine malformation, clinical signs of intracranial hypertension, cutaneous infection at the puncture site).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of VRG50635 in Healthy Volunteers
The primary objectives of this study are to investigate the safety and tolerability of VRG50635 and to determine how VRG50635 is absorbed by the body.
Read the detailed description
This is a Phase 1, randomized, single-center study conducted in 2 parts to evaluate the safety, tolerability, and PK of VRG50635 following single and multiple doses in healthy participants. The study will consist of a screening period, onsite dosing phase(s), and follow-up period.
- Conditions
- Healthy Volunteers
- Being tested
- VRG50635, Placebo
- Keywords
- Amyotrophic lateral sclerosis, ALS
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRG50635Drug
Specified dose on specified days
PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part 1: VRG50635 Sequence A, B, C | Experimental | Participants will receive a single dose of VRG50635 in each of 3 treatment periods separated by 14-day washout periods. Receives: Drug: VRG50635 |
| Part 1: VRG50635 Sequence B, A, C | Experimental | Participants will receive a single dose of VRG50635 in each of 3 treatment periods separated by 14-day washout periods. Receives: Drug: VRG50635 |
| Part 2: Cohort 1 VRG50635 | Experimental | Participants will receive VRG50635 (Dose X) for 14 consecutive days. Receives: Drug: VRG50635 |
| Part 2: Cohort 1 Placebo | Placebo comparator | Participants will receive VRG50635-matching placebo for 14 consecutive days. Receives: Drug: Placebo |
| Part 2: Cohort 2 VRG50635 | Experimental | Participants will receive VRG50635 (Dose Y) for 14 consecutive days. Receives: Drug: VRG50635 |
| Part 2: Cohort 2 Placebo | Placebo comparator | Participants will receive VRG50635-matching placebo for 14 consecutive days. Receives: 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
Measured: Up to Day 30
Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUCinf)
Measured: Up to Day 16
Area Under the Concentration-time Curve from Time 0 to the Last Measurable Concentration (AUClast)
Measured: Up to Day 16
Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-dose (AUC0-24)
Measured: Up to Day 16
Area Under the Concentration-time Curve Between Consecutive Doses (AUCtau)
Measured: Up to Day 16
Maximum Observed Concentration (Cmax)
Measured: Up to Day 16
Half-life (t1/2)
Measured: Up to Day 16
Time of Maximal Plasma Concentration (tmax)
Measured: Up to Day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start29 Feb 2024
- Primary completion25 Mar 2024
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Model description
- This is a 2-part study that includes both an open-label (Part 1) and a double-blind, placebo-controlled (Part 2) design. In Part 1, participants will be randomly assigned to receive open-label VRG50635 in 1 of 2 treatment sequences. In Part 2, participants will receive VRG50635 or placebo in a double-blind manner.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verge Genomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diego Cadavid, MD, Study director, Verge Genomics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286475
- Sponsor's protocol ID
- VGCS-50635-003
- Status last verified
- Dec 2025
- First submitted
- 21 Feb 2024
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hung ST, Linares GR, Chang WH, Eoh Y, Krishnan G, Mendonca S, Hong S, Shi Y, Santana M, Kueth C, Macklin-Isquierdo S, Perry S, Duhaime S, Maios C, Chang J, Perez J, Couto A, Lai J, Li Y, Alworth SV, Hendricks E, Wang Y, Zlokovic BV, Dickman DK, Parker JA, Zarnescu DC, Gao FB, Ichida JK. PIKFYVE inhibition mitigates disease in models of diverse forms of ALS. Cell. 2023 Feb 16;186(4):786-802.e28. doi: 10.1016/j.cell.2023.01.005. Epub 2023 Feb 7.
PubMed 36754049Shi Y, Lin S, Staats KA, Li Y, Chang WH, Hung ST, Hendricks E, Linares GR, Wang Y, Son EY, Wen X, Kisler K, Wilkinson B, Menendez L, Sugawara T, Woolwine P, Huang M, Cowan MJ, Ge B, Koutsodendris N, Sandor KP, Komberg J, Vangoor VR, Senthilkumar K, Hennes V, Seah C, Nelson AR, Cheng TY, Lee SJ, August PR, Chen JA, Wisniewski N, Hanson-Smith V, Belgard TG, Zhang A, Coba M, Grunseich C, Ward ME, van den Berg LH, Pasterkamp RJ, Trotti D, Zlokovic BV, Ichida JK. Haploinsufficiency leads to neurodegeneration in C9ORF72 ALS/FTD human induced motor neurons. Nat Med. 2018 Mar;24(3):313-325. doi: 10.1038/nm.4490. Epub 2018 Feb 5.
PubMed 29400714Gontier G, Kim G, Wang C, Zhu K, Gau R, Zhang N, Naphade S, Stewart A, Schmidt MJ, Galemmo R, Shook B, Tarachandani A, Choi I, Raines S, Scannevin RH, Grievink HW, Smits LMG, Kremer PHC, Cadavid D. Glycoprotein Non-Metastatic Melanoma Protein B (GPNMB): A Translational Pharmacodynamic Biomarker for PIKfyve Inhibition With VRG50635. Clin Transl Sci. 2026 Feb;19(2):e70489. doi: 10.1111/cts.70489.
PubMed 41708347
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of VRG50635 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06286475
- Acronym / sponsor ID
- VGCS-50635-003
- Conditions
- Healthy Volunteers
- Keywords
- Amyotrophic lateral sclerosis, ALS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Verge GenomicsIndustry (pharma, biotech, devices)
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 25 Mar 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 29 Feb 2024 (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 objectives of this study are to investigate the safety and tolerability of VRG50635 and to determine how VRG50635 is absorbed by the body.
Detailed description
This is a Phase 1, randomized, single-center study conducted in 2 parts to evaluate the safety, tolerability, and PK of VRG50635 following single and multiple doses in healthy participants. The study will consist of a screening period, onsite dosing phase(s), and follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- This is a 2-part study that includes both an open-label (Part 1) and a double-blind, placebo-controlled (Part 2) design. In Part 1, participants will be randomly assigned to receive open-label VRG50635 in 1 of 2 treatment sequences. In Part 2, participants will receive VRG50635 or placebo in a double-blind manner.
| Arm | Type | Receives |
|---|---|---|
| Part 1: VRG50635 Sequence A, B, C | Experimental | Drug: VRG50635Participants will receive a single dose of VRG50635 in each of 3 treatment periods separated by 14-day washout periods. |
| Part 1: VRG50635 Sequence B, A, C | Experimental | Drug: VRG50635Participants will receive a single dose of VRG50635 in each of 3 treatment periods separated by 14-day washout periods. |
| Part 2: Cohort 1 VRG50635 | Experimental | Drug: VRG50635Participants will receive VRG50635 (Dose X) for 14 consecutive days. |
| Part 2: Cohort 1 Placebo | Placebo comparator | Drug: PlaceboParticipants will receive VRG50635-matching placebo for 14 consecutive days. |
| Part 2: Cohort 2 VRG50635 | Experimental | Drug: VRG50635Participants will receive VRG50635 (Dose Y) for 14 consecutive days. |
| Part 2: Cohort 2 Placebo | Placebo comparator | Drug: PlaceboParticipants will receive VRG50635-matching placebo for 14 consecutive days. |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must be ≥ 19 and ≤ 55 years of age at Screening.
- Must be willing and able to voluntarily give written informed consent by signing an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form prior to any study-related procedures being performed.
- Must have a body mass index ≥ 18.5 and ≤ 32 kilogram per square meter (kg/m2) and weigh ≥ 50 kg.
- Participants of childbearing potential are eligible to participate if they are not pregnant or breastfeeding and agree to use one highly effective and one barrier method of contraception, if sexually active, for the duration of the study through 90 days after the last study drug administration. Participants must not donate eggs for the duration of study through 90 days after the last dose of study drug.
- Participants capable of producing sperm must agree that they will use one barrier method of contraception and that their partners of childbearing potential will use one highly effective method of contraception for the duration of the study through 90 days after the last study drug administration. Participants must not donate sperm for the duration of study through 90 days after the last dose of study drug.
Key exclusion criteria (27 listed)
- Have a history of clinically significant hematologic, renal, neurologic, pancreatic, gastrointestinal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, immunological, allergic disease, or other major disorders, as determined by the PI.
- Have any surgical or medical condition that could possibly affect drug absorption (including inflammatory bowel disease, history of gastrectomy, cholecystectomy, or other gastrointestinal tract surgery except appendectomy).
- Have a current significant medical or psychiatric condition, as determined by the PI.
- Have a history of serious adverse reaction or serious hypersensitivity to any drug.
- Have, in the opinion of the PI, evidence of clinically significant hepatic or renal impairment including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > the upper limit of normal (ULN) or bilirubin > 1.5 × ULN. Note: Participants with Gilbert syndrome without evidence of hepatic impairment may be enrolled.
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 |
|---|---|---|
| VRG50635Specified dose on specified days | Drug | Part 1: VRG50635 Sequence A, B, C, Part 1: VRG50635 Sequence B, A, C, Part 2: Cohort 1 VRG50635, Part 2: Cohort 2 VRG50635 |
| PlaceboSpecified dose on specified days | Drug | Part 2: Cohort 1 Placebo, Part 2: Cohort 2 Placebo |
Primary outcome
Number of Participants with Adverse Events
Time frame: Up to Day 30
Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUCinf)
Time frame: Up to Day 16
Area Under the Concentration-time Curve from Time 0 to the Last Measurable Concentration (AUClast)
Time frame: Up to Day 16
Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-dose (AUC0-24)
Time frame: Up to Day 16
Area Under the Concentration-time Curve Between Consecutive Doses (AUCtau)
Time frame: Up to Day 16
Maximum Observed Concentration (Cmax)
Time frame: Up to Day 16
Half-life (t1/2)
Time frame: Up to Day 16
Time of Maximal Plasma Concentration (tmax)
Time frame: Up to Day 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Background: PubMed 36754049Hung ST, Linares GR, Chang WH, Eoh Y, Krishnan G, Mendonca S, Hong S, Shi Y, Santana M, Kueth C, Macklin-Isquierdo S, Perry S, Duhaime S, Maios C, Chang J, Perez J, Couto A, Lai J, Li Y, Alworth SV, Hendricks E, Wang Y, Zlokovic BV, Dickman DK, Parker JA, Zarnescu DC, Gao FB, Ichida JK. PIKFYVE inhibition mitigates disease in models of diverse forms of ALS. Cell. 2023 Feb 16;186(4):786-802.e28. doi: 10.1016/j.cell.2023.01.005. Epub 2023 Feb 7.
- Background: PubMed 29400714Shi Y, Lin S, Staats KA, Li Y, Chang WH, Hung ST, Hendricks E, Linares GR, Wang Y, Son EY, Wen X, Kisler K, Wilkinson B, Menendez L, Sugawara T, Woolwine P, Huang M, Cowan MJ, Ge B, Koutsodendris N, Sandor KP, Komberg J, Vangoor VR, Senthilkumar K, Hennes V, Seah C, Nelson AR, Cheng TY, Lee SJ, August PR, Chen JA, Wisniewski N, Hanson-Smith V, Belgard TG, Zhang A, Coba M, Grunseich C, Ward ME, van den Berg LH, Pasterkamp RJ, Trotti D, Zlokovic BV, Ichida JK. Haploinsufficiency leads to neurodegeneration in C9ORF72 ALS/FTD human induced motor neurons. Nat Med. 2018 Mar;24(3):313-325. doi: 10.1038/nm.4490. Epub 2018 Feb 5.
- Derived from this study: PubMed 41708347Gontier G, Kim G, Wang C, Zhu K, Gau R, Zhang N, Naphade S, Stewart A, Schmidt MJ, Galemmo R, Shook B, Tarachandani A, Choi I, Raines S, Scannevin RH, Grievink HW, Smits LMG, Kremer PHC, Cadavid D. Glycoprotein Non-Metastatic Melanoma Protein B (GPNMB): A Translational Pharmacodynamic Biomarker for PIKfyve Inhibition With VRG50635. Clin Transl Sci. 2026 Feb;19(2):e70489. doi: 10.1111/cts.70489.
- 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.
Diego Cadavid, MD study director
Verge Genomics
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 VRG50635 in people with Healthy Volunteers, run by Verge Genomics 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 5 inclusion and 27 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: finished, as of the sponsor's last update on 15 Dec 2025. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: Up to Day 30). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06286475, which also lists 3 linked publications.
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 15 Dec 2025.