Herpes Simplex VirusPhase 1NCT06435507
Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of IM-250 in Healthy Volunteers
A Phase 1 study testing IM-250 (50 mg), IM-250 (100 mg) and IM-250 (200 mg) in people with Herpes Simplex Virus, run by Innovative Molecules GmbH at 1 site in Germany.
Trial summary
This is a first-in-human, phase I, open-label, monocenter, single dose-escalation study with 4 cohorts. The total trial duration for each participant will be not more than 98 d from screening to the end of the follow-up. Twenty-four participants are planned to be enrolled in the trial. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Herpes Simplex Virus
- What is being tested?
- IM-250 (50 mg), IM-250 (100 mg) and IM-250 (200 mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteGermany
- Study dates
- 25 Apr 2023to 28 May 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed Informed Consent Form (ICF),
- Age 18-50 y inclusive at the time of consent,
- An understanding, ability, and willingness to fully comply with study interventions and restrictions,
- Males who are willing to use a condom for contraception during the treatment and for 60 d after IMP administration, or who are convincingly sexually abstinent, or who are refraining from heterosexual intercourse; females who are willing to use a highly effective method for contraception during the treatment and for 90 d after IMP administration, or who are convincingly sexually abstinent, or who are refraining from heterosexual intercourse, or women not of child-bearing potential (WNOCBP).
- Satisfactory medical assessment without clinically significant or relevant abnormalities as determined by medical history, physical examination (PE), clinical (vital signs including normal heart rate [50-90 bpm]), laboratory (hematology, biochemistry, urinalysis), and electrocardiographic (ECG) evaluation (corrected QTc interval within normal range). First degree AV blocks may be acceptable, if the pulse rate complies with the inclusion criteria.
- Ability to provide written, personally signed and dated informed consent to participate in the study, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related interventions.
Who cannot join
- Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the IMP or study interventions.
- Any intake of substances (prescription medication, over-the-counter medicine, or herbal preparations with active ingredients) known to inhibit drug-metabolizing enzymes or transport enzymes within a period of less than 5 times the respective elimination t1/2 with regard to the expected date of IMP administration (except iodine, hormone replacement therapy, hormonal contraception, and levothyroxine).
- Any intake of substances (prescription medication, over-the-counter medicine, or herbal preparations with active ingredients) known to induce drug-metabolizing enzymes or transport enzymes within a period of 14 d with regard to the expected date of IMP administration.
- A positive result in testing for illegal drugs at screening and enrollment.
- Male participants who consume more than 21 units of alcohol per week or 3 units per day. Female participants who consume more than 14 units of alcohol per week or 2 units per day.
- Consumption of alcohol within 24 h prior to Day 1 and until End of Study (EOS).
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- Clinically relevant abnormalities regarding ECG conduction (AV block), hematocrit, hemoglobin (Hb), platelets, or leucocytes. A Hb value > 12 g / dl (males) or > 11 g / dl (females) is acceptable.
- Abnormal renal function as defined by estimated creatinine clearance: < 90 ml / min (Cockcroft-Gault equation).
- Alanine aminotransferase (ALT) > ULN x 1.1; aspartate aminotransferase (AST) > ULN x 1.2.
- Thyroid-stimulating hormone (TSH) not within normal limits. If thyroid hormones are supplemented, reduced TSH values are acceptable, if free thyroxine (T4) and free triiodothyronine (T3), are within the normal range.
- Total bilirubin > upper limit of normal (ULN) x 1.2; In case of suspected Gilbert´s disease: total bilirubin ≤ ULN x 3 is acceptable.
- Any history of severe allergic or anaphylactic reactions to drugs or food or any other clinically significant allergies.
- Known allergy / hypersensitivity to additives used in the IMP.
- Use of another IMP within 30 d prior to receiving the dose of IMP or active enrolment in another drug or vaccine clinical trial.
- A positive human antibody screen for immunodeficiency virus (HIV), or chronic hepatitis C virus (HCV), or a positive hepatitis B antigen (HBsAg) test.
- History of immunization within 14 d prior to expected dosing, including SARS-CoV-2 vaccinations, and / or plans to get vaccinated during the observation time
- Pregnancy or breast feeding
- Prior exposure in this trial.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Heidelberg, Department of Clinical Pharmacology and Pharmacoepidemiology
Heidelberg
About this study
This is a first-in-human, phase I, open-label, monocenter, single dose-escalation study with 4 cohorts. The total trial duration for each participant will be not more than 98 d from screening to the end of the follow-up.
Twenty-four participants are planned to be enrolled in the trial. Each cohort may be expanded by up to 6 additional volunteers, resulting in a maximum of 48 participants possibly enrolled in the trial.
Ninety-six volunteers may need to be screened to include 48 volunteers.
- Conditions
- Herpes Simplex Virus
- Being tested
- IM-250 (50 mg), IM-250 (100 mg), IM-250 (200 mg), IM-250 (400 mg)
- Medical subject headings
- Herpes Simplex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM-250 (50 mg)Drug
Single dose
IM-250 (100 mg)Drug
Single dose
IM-250 (200 mg)Drug
Single dose
IM-250 (400 mg)Drug
Single dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 6 participants Receives: Drug: IM-250 (50 mg) |
| Cohort 2 | Experimental | 6 participants Receives: Drug: IM-250 (100 mg) |
| Cohort 3 | Experimental | 6 participants Receives: Drug: IM-250 (200 mg) |
| Cohort 4 | Experimental | 6 participants Receives: Drug: IM-250 (400 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence (number) of dose-limiting toxicities (DLT)
- Serious adverse reaction (i.e., a serious adverse event (SAE) considered at least possibly related to IMP administration)
- Severe (CTCAE grade III) non-serious adverse reactions (i.e., severe non-serious adverse event (AE) considered as, at least, possibly related to IMP administration) lasting more than 72 h
Measured: within 28 days after exposure
Secondary outcomes (3)
PK: The area under the plasma concentration-time curve extrapolated to infinity (AUC∞)
Non-compartmental pharmacokinetic (PK) analysis (NCA) of IM-250 plasma concentrations (exposure with different doses)
Measured: 56 days
PK: Maximum plasma concentration (Cmax)
Non-compartmental pharmacokinetic (PK) analysis (NCA) of IM-250 plasma concentrations (exposure with different doses)
Measured: 8 days
PK: Concentration at 24 h (C24h), 5 d (C5d), and 8 d (C8d)
Non-compartmental pharmacokinetic (PK) analysis (NCA) of IM-250 plasma concentrations (exposure with different doses)
Measured: 24 hours, 5 days and 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start25 Apr 2023
- Primary completion30 Jan 2024
- Study completion28 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Herpes Simplex VirusStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovative Molecules GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06435507
- Sponsor's protocol ID
- IM-101
- Status last verified
- Oct 2024
- First submitted
- 20 May 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of IM-250 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06435507
- Acronym / sponsor ID
- IM-101
- Conditions
- Herpes Simplex Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Innovative Molecules GmbHIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 28 May 2024 (actual)
- First posted
- 30 May 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.
This is a first-in-human, phase I, open-label, monocenter, single dose-escalation study with 4 cohorts. The total trial duration for each participant will be not more than 98 d from screening to the end of the follow-up.
Twenty-four participants are planned to be enrolled in the trial. Each cohort may be expanded by up to 6 additional volunteers, resulting in a maximum of 48 participants possibly enrolled in the trial.
Ninety-six volunteers may need to be screened to include 48 volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: IM-250 (50 mg)6 participants |
| Cohort 2 | Experimental | Drug: IM-250 (100 mg)6 participants |
| Cohort 3 | Experimental | Drug: IM-250 (200 mg)6 participants |
| Cohort 4 | Experimental | Drug: IM-250 (400 mg)6 participants |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Signed Informed Consent Form (ICF),
- Age 18-50 y inclusive at the time of consent,
- An understanding, ability, and willingness to fully comply with study interventions and restrictions,
- Males who are willing to use a condom for contraception during the treatment and for 60 d after IMP administration, or who are convincingly sexually abstinent, or who are refraining from heterosexual intercourse; females who are willing to use a highly effective method for contraception during the treatment and for 90 d after IMP administration, or who are convincingly sexually abstinent, or who are refraining from heterosexual intercourse, or women not of child-bearing potential (WNOCBP).
- Satisfactory medical assessment without clinically significant or relevant abnormalities as determined by medical history, physical examination (PE), clinical (vital signs including normal heart rate [50-90 bpm]), laboratory (hematology, biochemistry, urinalysis), and electrocardiographic (ECG) evaluation (corrected QTc interval within normal range). First degree AV blocks may be acceptable, if the pulse rate complies with the inclusion criteria.
Key exclusion criteria (18 listed)
- Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the IMP or study interventions.
- Any intake of substances (prescription medication, over-the-counter medicine, or herbal preparations with active ingredients) known to inhibit drug-metabolizing enzymes or transport enzymes within a period of less than 5 times the respective elimination t1/2 with regard to the expected date of IMP administration (except iodine, hormone replacement therapy, hormonal contraception, and levothyroxine).
- Any intake of substances (prescription medication, over-the-counter medicine, or herbal preparations with active ingredients) known to induce drug-metabolizing enzymes or transport enzymes within a period of 14 d with regard to the expected date of IMP administration.
- A positive result in testing for illegal drugs at screening and enrollment.
- Male participants who consume more than 21 units of alcohol per week or 3 units per day. Female participants who consume more than 14 units of alcohol per week or 2 units per day.
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 |
|---|---|---|
| IM-250 (50 mg)Single dose | Drug | Cohort 1 |
| IM-250 (100 mg)Single dose | Drug | Cohort 2 |
| IM-250 (200 mg)Single dose | Drug | Cohort 3 |
| IM-250 (400 mg)Single dose | Drug | Cohort 4 |
Primary outcome
Occurrence (number) of dose-limiting toxicities (DLT)
Time frame: within 28 days after exposure
* Serious adverse reaction (i.e., a serious adverse event (SAE) considered at least possibly related to IMP administration) * Severe (CTCAE grade III) non-serious adverse reactions (i.e., severe non-serious adverse event (AE) considered as, at least, possibly related to IMP administration) lasting more than 72 h
3 secondary outcomes
PK: The area under the plasma concentration-time curve extrapolated to infinity (AUC∞)
Time frame: 56 days
PK: Maximum plasma concentration (Cmax)
Time frame: 8 days
PK: Concentration at 24 h (C24h), 5 d (C5d), and 8 d (C8d)
Time frame: 24 hours, 5 days and 8 days
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 24 Oct 2024.
- 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 IM-250 (50 mg), IM-250 (100 mg) and IM-250 (200 mg) in people with Herpes Simplex Virus, run by Innovative Molecules GmbH at 1 site in Germany.
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 6 inclusion and 18 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 24 Oct 2024. 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 Germany. 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?
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?
Occurrence (number) of dose-limiting toxicities (DLT) (time frame: within 28 days after exposure). 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 24 Oct 2024.