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Not Applicable

AL101 SC for Healthy Subjects

Phase 1
Waitlist Available
Led By Maria Bermudez
Research Sponsored by Alector Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up either 57, 113, or 141 days, depending on the cohort
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and works in healthy volunteers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~either 57, 113, or 141 days, depending on the cohort
This trial's timeline: 3 weeks for screening, Varies for treatment, and either 57, 113, or 141 days, depending on the cohort for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluation of safety and tolerability of AL101 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs)
Secondary outcome measures
Area under the curve concentration (AUC) for AL101
Maximum plasma concentration (Cmax) for AL101
Pharmacokinetics (PK) of AL101

Side effects data

From 2022 Phase 2 trial • 87 Patients • NCT03691207
79%
Diarrhoea
60%
Fatigue
45%
Nausea
43%
Hypophosphataemia
38%
Cough
33%
Epistaxis
31%
Dry mouth
31%
Vomiting
29%
Insomnia
29%
Decreased appetite
26%
Weight decreased
24%
Constipation
21%
Dysgeusia
19%
Dyspnoea
19%
Dermatitis acneiform
19%
Rash
17%
Stomatitis
17%
Dry skin
17%
Alopecia
17%
Asthenia
17%
Rash maculo-papular
14%
Hypokalaemia
12%
Hypocalcaemia
12%
Oropharyngeal pain
12%
Pruritus
12%
Dysphonia
12%
Mucosal inflammation
10%
Dehydration
10%
Aspartate aminotransferase increased
10%
Dyspepsia
10%
Pneumonia
10%
Dizziness
10%
Productive cough
10%
Oral pain
10%
Headache
10%
Back pain
10%
Dry eye
10%
Hypertension
10%
Hyperglycaemia
10%
Alanine aminotransferase increased
10%
Platelet count decreased
10%
Anaemia
7%
Swelling face
7%
Abdominal pain upper
7%
Gastrooesophageal reflux disease
7%
Arthralgia
7%
Neuralgia
7%
Neutrophil count increased
7%
Pyrexia
7%
Hypoxia
7%
Facial pain
7%
Oedema peripheral
7%
Infusion related reaction
7%
Dysphagia
7%
Candida infection
7%
Oral candidiasis
7%
Erythema
7%
Night sweats
7%
Palmar-plantar erythrodysaesthesia syndrome
7%
Vision blurred
7%
Urinary tract infection
5%
Cardiac arrest
5%
Pneumonia aspiration
5%
Anxiety
5%
Nasal dryness
5%
Skin lesion
5%
Depression
2%
Ejection fraction decreased
2%
Musculoskeletal pain
2%
Encephalopathy
2%
Sepsis
2%
Femoral neck fracture
2%
Abdominal pain
2%
Pneumonia pseudomonal
2%
Brain neoplasm
2%
Respiratory failure
2%
Eosinophilic pneumonia
2%
Brain cancer metastatic
2%
Clostridium difficile colitis
2%
Abdominal infection
2%
Acute respiratory distress syndrome
2%
Squamous cell carcinoma
2%
Vasculitis
2%
Bronchial obstruction
2%
Upper-airway cough syndrome
2%
Metastases to central nervous system
2%
Cellulitis
2%
Anorectal infection
2%
Streptococcal bacteraemia
2%
Drug-induced liver injury
2%
Haemoptysis
2%
Pleural effusion
2%
Pneumonitis
2%
Hepatobiliary disease
2%
Nasal congestion
2%
Hyponatraemia
2%
Pathological fracture
2%
Campylobacter sepsis
2%
Chills
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2 - AL101 6mg
Cohort 1 - AL101 4mg

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: AL101 SCExperimental Treatment1 Intervention
Single fixed dose levels of AL101 administered SC Multiple fixed dose of AL101 administered SC
Group II: AL101 IVExperimental Treatment1 Intervention
Up to four single ascending doses (SAD IV cohorts) Multiple doses of AL101 administered IV (MD IV cohort)
Group III: Saline SolutionPlacebo Group1 Intervention
Saline solution will be administered with the following: Single IV infusion for four single ascending doses (SAD IV cohorts) in a ratio of 8 active and 3 placebo subjects Multiple IV infusions for the MD IV cohort in a ratio of 8 active and 2 placebo subjects
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AL101
2018
Completed Phase 2
~180

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Alector Inc.Lead Sponsor
10 Previous Clinical Trials
1,197 Total Patients Enrolled
Maria BermudezPrincipal InvestigatorQuotient Sciences
Jorge KusnirPrincipal InvestigatorBioclinica Research

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Florida
How old are they?
18 - 65
What site did they apply to?
Study site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Phase 1 First in Human Study to Assess Safety and Tolerability of AL101
2019. "A Phase 1 First in Human Study to Assess Safety and Tolerability of AL101". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04111666.
~16 spots leftby Apr 2025
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