Glucocorticoids ToxicityPhase 1NCT05619770
Study to Evaluate Pharmacokinetics, Safety & Tolerability of 101-PGC-005 in Healthy, Adult, Human Subjects
A Phase 1 study testing 101-PGC-005 in people with Glucocorticoids Toxicity and COVID-19, run by 101 Therapeutics at 1 site in India.
Trial summary
The goal of this interventional study is to evaluate the pharmacokinetics, safety, and tolerability of 101-PGC-005 in healthy, adult, human subjects. The main question it aims to answer is what are the single and multi-dose PK properties of 101-PGC-005 in the systemic circulation Participants will receive a bolus… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Glucocorticoids Toxicity, COVID-19, Infectious Disease
- What is being tested?
- 101-PGC-005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteIndia
- Study dates
- 29 Oct 2022to 15 Jan 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing to provide audio-visual \& written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study.
- Willing to be available for the entire study period and to comply with protocol requirements. Should have reliable access to the clinical trial center and be available in the area for at least one month.
- Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age.
- Body mass index in the range of 18 -30 kg/m2 (both inclusive).
- Healthy volunteers who are clinically non-anemic will be included as per the discretion of PI/CI/Physician.
- Non-diabetic healthy adult with HbA1c < 5.5 at the time of study entry
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- Normal health status as determined by baseline medical and medication history, at the time of screening and vital signs (blood pressure, pulse rate, respiratory rate, and axillary temperature) measurements and physical examination at the time screening as well as check-in during each study period.
- With normal or clinically non-significant laboratory values as determined by hematological, biochemistry tests and urine analysis (included in section no. 9.1).
- With a normal or clinically non-significant 12-lead ECG.
- With a negative test for Human Immunodeficiency Virus (HIV) type I/II antibodies or Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibodies.
- Non-smokers and should not have been consuming any kind of tobacco products including chewing or inhaling tobacco in the form of jarda, pan, gutkha etc, Or, In case of smokers, they should be willing to abstain from smoking or chewing any tobacco containing product for at least 72.00 hours prior to check-in and throughout the duration of the study till safety samples are collected at the end of the study.
- In case of female subjects:
- Negative urine pregnancy test during screening and negative serum β- hCG test at check-in.
- Female subjects with childbearing potential must either abstain from sexual intercourse or use acceptable methods of birth control for at least 15 days before 1st dose till 15 days post last-dose/ entire study period [Acceptable birth control methods include barrier methods such as diaphragm/condom with or without spermicide or who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy has been performed)].
- They should not be menstruating on the day of the withdrawal of blood, when blood is collected for the purpose of study. Ability to communicate effectively.
Who cannot join
- History of allergy or hypersensitivity intolerance to Dexamethasone or its formulation excipients which, in the opinion of the clinical investigator, would compromise the safety of the subject or the study.
- Has consumed dexamethasone or any other corticosteroid oral or intravenous for any reasons in past 4 weeks before study entry.
- Hemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for women.
- Any medical or surgical conditions, which might significantly interfere with the normal functioning of the body or blood forming organs.
- History of severe infection or major surgery in the past 6 months.
- History of Minor surgery or fracture within the past 3 months.
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- Significant history or current evidence of malignancy or chronic - infectious, cardiovascular, renal, hepatic, ophthalmic, pulmonary, neurological, metabolic (endocrine), hematological, gastrointestinal, immunological or psychiatric diseases, or organ dysfunction.
- Any major illness or hospitalized within 90 days prior to check-in.
- Any other clinical condition like diarrhea or vomiting within three days prior to dosing.
- Subjects who have been on an unusual or abnormal diet, for whatever reason e.g. because of fasting due to religious reasons during the four weeks before screening.
- Use of any depot injection or an implant of any drug within three months prior to dosing and throughout the study periods.
- Use of any prescribed medication (including herbal medicines and vitamin supplements) within 14 days or within five half-lives of the drug, whichever is longer prior to dosing and throughout the duration of the study until the post study safety sample is collected.
- Use of any OTC products within 7 days or within five half-lives of the drug, whichever is longer prior to first check-in and throughout the duration of the study until the post study safety sample is collected.
- History or presence of gastric or duodenal ulcer or GI bleeding or blood in stools anytime in the past.
- Use of any recreational drug or history of drug addiction.
- Participated in any clinical investigation requiring repeated blood sampling, blood donation, or have blood loss of >300 mL in past 90 days prior to dosing.
- Participated in any clinical study within the past 90 days prior to check-in.
- Use of any Investigational vaccine within the last three years except for Covid-19 vaccines.
- History of Chronic systemic immunosuppressive medications usage for any reasons.
- Consumption of alcohol or alcoholic products within 72.00 hrs prior to dosing in each study period and throughout sampling time points.
- Positive alcohol breath or urine screen for drug of abuse tests during check-in study period.
- > Positive test for alcohol in breath, or drugs of abuse (including benzodiazepines, amphetamines, barbiturates, cocaine, methadone, phencyclidine, 3,4-methylenedioxymethamphetamine [MDMA/ecstasy], tetrahydrocannabinol, and opiates) in urine.
- Consumption of xanthine or its derivative containing food or beverages (e.g. chocolates, tea, coffee or cola drinks) within 48.00 hours prior to dosing in each study period and throughout sampling time points.
- Lactating or nursing female subjects.
- Female subjects using hormonal contraceptive (either oral/implants).
- Any history of difficulty in blood sampling or any vasovagal attack during blood sampling which in the opinion of the Investigator may relevantly interfere with the study sampling.
- Evidence of an uncooperative attitude.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Arm, Open Label, Single Dose and Multiple Dose Study to Evaluate Pharmacokinetics, Safety & Tolerability of 101-PGC-005 in Healthy, Adult, Human Subjects
The goal of this interventional study is to evaluate the pharmacokinetics, safety, and tolerability of 101-PGC-005 in healthy, adult, human subjects. The main question it aims to answer is what are the single and multi-dose PK properties of 101-PGC-005 in the systemic circulation
Participants will receive a bolus injection of 101-PGC-005 administered intravenously once daily for 3 consecutive days. Blood and urine samples will be collected at predetermined timepoints for analysis.
- Conditions
- Glucocorticoids Toxicity, COVID-19, Infectious Disease, Virus Diseases
- Being tested
- 101-PGC-005
- Medical subject headings
- COVID-19, Communicable Diseases, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
101-PGC-005Drug
Bolus Injection containing 30mg of 101-PGC-005 will administered intravenously once daily for 3 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| 101-PGC-005 (Intervention arm) | Experimental | Bolus Injection containing 30mg of 101-PGC-005 will administered intravenously once daily for 3 consecutive days Receives: Drug: 101-PGC-005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single dose PK
Quantification of 101-PGC-005 concentration available in
systemic circulation (blood/plasma) in all recruited subjects; pre- and post- dosing with 101-PGC-005 injection on Day 1.
Measured: -0.5, 0.5, 0.75, 1, 1.5, 2, 3, 6, 9, 12, 24 hours post-dose
Multiple dose PK
Quantification of 101-PGC-005 concentration available in systemic circulation (blood/plasma) in all recruited subjects; pre- and post- dosing with 101-PGC-005 injection on Day 3.
Measured: -0.5, 0.5, 0.75, 1, 1.5, 2, 3, 6, 9, 12, 24 hours post-dose
Secondary outcomes (2)
Evaluate free dexamethasone levels
To evaluate free dexamethasone levels available in systemic circulation (blood/plasma) in all recruited subjects; pre- and post- dosing with 101- PGC-005 injection on Day 1 \& Day 3.
Measured: -0.5, 0.5, 0.75, 1, 1.5, 2, 3, 6, 9, 12, 24 hours post-dose
Evaluate steroid induced hyperglycemia
To evaluate the incidence of steroid-induced hyperglycemia events after 101-PGC-005 administration
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start29 Oct 2022
- Primary completion3 Nov 2022
- Study completion15 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucocorticoids ToxicityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- 101 Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05619770
- Sponsor's protocol ID
- PGC-005-IN-101
- Status last verified
- Dec 2022
- First submitted
- 3 Nov 2022
- Last updated
- 14 Dec 2022
- 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 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open Label, Single Dose and Multiple Dose Study to Evaluate Pharmacokinetics, Safety & Tolerability of 101-PGC-005 in Healthy, Adult, Human Subjects
- ClinicalTrials.gov ID
- NCT05619770
- Acronym / sponsor ID
- PGC-005-IN-101
- Conditions
- Glucocorticoids Toxicity, COVID-19, Infectious Disease, Virus Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (actual)
- Lead sponsor
- 101 TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2022 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 15 Jan 2023 (estimated)
- First posted
- 17 Nov 2022 (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 goal of this interventional study is to evaluate the pharmacokinetics, safety, and tolerability of 101-PGC-005 in healthy, adult, human subjects. The main question it aims to answer is what are the single and multi-dose PK properties of 101-PGC-005 in the systemic circulation
Participants will receive a bolus injection of 101-PGC-005 administered intravenously once daily for 3 consecutive days. Blood and urine samples will be collected at predetermined timepoints for analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 101-PGC-005 (Intervention arm) | Experimental | Drug: 101-PGC-005Bolus Injection containing 30mg of 101-PGC-005 will administered intravenously once daily for 3 consecutive days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Willing to provide audio-visual \& written informed consent for participation in the study, and an ability to comprehend the nature and purpose of the study.
- Willing to be available for the entire study period and to comply with protocol requirements. Should have reliable access to the clinical trial center and be available in the area for at least one month.
- Normal, healthy, adult, human subject of 18-45 years (both inclusive) of age.
- Body mass index in the range of 18 -30 kg/m2 (both inclusive).
- Healthy volunteers who are clinically non-anemic will be included as per the discretion of PI/CI/Physician.
Key exclusion criteria (27 listed)
- History of allergy or hypersensitivity intolerance to Dexamethasone or its formulation excipients which, in the opinion of the clinical investigator, would compromise the safety of the subject or the study.
- Has consumed dexamethasone or any other corticosteroid oral or intravenous for any reasons in past 4 weeks before study entry.
- Hemoglobin level less than 12.5 grams per deciliter for men and 12 grams per deciliter for women.
- Any medical or surgical conditions, which might significantly interfere with the normal functioning of the body or blood forming organs.
- History of severe infection or major surgery in the past 6 months.
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 |
|---|---|---|
| 101-PGC-005Bolus Injection containing 30mg of 101-PGC-005 will administered intravenously once daily for 3 consecutive days | Drug | 101-PGC-005 (Intervention arm) |
Primary outcome
Single dose PK
Time frame: -0.5, 0.5, 0.75, 1, 1.5, 2, 3, 6, 9, 12, 24 hours post-dose
Quantification of 101-PGC-005 concentration available in systemic circulation (blood/plasma) in all recruited subjects; pre- and post- dosing with 101-PGC-005 injection on Day 1.
Multiple dose PK
Time frame: -0.5, 0.5, 0.75, 1, 1.5, 2, 3, 6, 9, 12, 24 hours post-dose
Quantification of 101-PGC-005 concentration available in systemic circulation (blood/plasma) in all recruited subjects; pre- and post- dosing with 101-PGC-005 injection on Day 3.
2 secondary outcomes
Evaluate free dexamethasone levels
Time frame: -0.5, 0.5, 0.75, 1, 1.5, 2, 3, 6, 9, 12, 24 hours post-dose
Evaluate steroid induced hyperglycemia
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- 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 101-PGC-005 in people with Glucocorticoids Toxicity and COVID-19, run by 101 Therapeutics at 1 site in India.
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 15 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: status not confirmed, as of the sponsor's last update on 14 Dec 2022. 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 India. 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?
Results are not available in the source record.
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?
Single dose PK (time frame: -0.5, 0.5, 0.75, 1, 1.5, 2, 3, 6, 9, 12, 24 hours post-dose). The study lists 2 primary outcomes in all. 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 14 Dec 2022.